Abecma (idecabtagene vicleucel) is a CAR T-cell therapy used for treating relapsed or refractory multiple myeloma in certain adults. Abecma is a personalized one-time infusion made from a patient’s own white blood cells, which are genetically modified to recognize and attack multiple myeloma cells.

Abilify (aripiprazole) is an antipsychotic medication used to treat schizophrenia, bipolar I disorder, major depressive disorder, Tourette's disorder, and autistic disorder in certain patients. Abilify helps to improve symptoms in these conditions by changing the activity of dopamine and serotonin in the brain.

Abilify belongs to a class of medications called atypical antipsychotics. Abilify is also available as Abilify Maintena, an injection given once a month, and Abilify Asimtufii, a long-acting injection administered every 2 months.

Abilify generic name is aripiprazole, and generic tablets and injections are available.

Abilify Asimtufii is an atypical antipsychotic used for schizophrenia and bipolar I disorder in adults. Abilify Asimtufii is an extended-release injection that is given once every two months; this helps compliance and means patients only need 6 injections per year.

Abilify Asimtufii is thought to work (mechanism of action) by balancing the levels of serotonin and dopamine in the brain, however, the exact mechanism of action for schizophrenia and bipolar I disorder is unknown.

Abilify Maintena (aripiprazole) extended-release injection is used alone or in combination with other aripiprazole preparations to treat schizophrenia (a mental illness that causes disturbed or unusual thinking, loss of interest in life, and strong or inappropriate emotions).

Abilify Maintena injection is also used for the ongoing treatment of people with bipolar I disorder (manic-depressive disorder; a disease that causes episodes of depression, episodes of mania, and other abnormal moods) Abilify Maintena belongs to a class of medications called atypical antipsychotics. It works by changing the activity of certain natural substances in the brain.

Abilify Maintena is an extended-release injectable suspension given once a month.

Abilify tablets are also available.

Abiraterone works by reducing androgen production in the body. Androgens are male hormones that can promote tumor growth in the prostate gland.

Abiraterone is used together with steroid medication (prednisone or methylprednisolone) to treat prostate cancer that has spread to other parts of the body. abiraterone is used in men whose prostate cancer cannot be treated with surgery or other medicines.

It is not known if abiraterone acetate tablets are safe or effective in females or children.

Acetaminophen is a pain reliever and a fever reducer.

Acetaminophen is used to treat mild to moderate pain, moderate to severe pain in conjunction with opiates, or to reduce fever. Common conditions treated include headache, muscle aches, arthritis, backache, toothaches, sore throat, colds, flu, and fevers.

Acetaminophen is also available in many over-the-counter combination medications with other drugs, including Actifed, Alka-Seltzer Plus Liquid Gels, Cepacol, Contac, Coridicin, Dayquil, Dimetapp, Dristan, Excedrin, Feverall, Liquiprin, Midol, Nyquil, Panadol, Robitussin Singlet, Sinutab, Sudafed, Theraflu, Triaminic, Vanquish, Vicks, and Zicam.

Acetaminophen is also found in many prescription combination drugs, including Butalbital, Endocet, Fioricet, Hycotab, Hydrocet, Hydrocodone bitartrate, Lortab, Percocet, Phenaphen, Sedapap, Tapanol, Tylenol with codeine, Tylox, Ultracet, Vicodin, and Zydone.

Active Immunity is defined as a form of acquired immunity in which the body produces its own antibodies against disease-causing antigens. It is the protection from a disease as a result of previous exposure to the disease-causing infectious agent or part of the infectious agent (antigen). Active immunity can be acquired in two ways, either by contracting the disease or through vaccination

Active Pharmaceutical Ingredient (API) is any substance or mixture of substances intended to be used in the manufacture of a drug (medicinal) product and that, when used in the production of a drug, becomes an active ingredient of the drug product. Such substances are intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure and function of the body.

Active Site is defined as a part of an enzyme where substrates bind and undergo a chemical reaction. The majority of enzymes are proteins but RNA enzymes called ribozymes also exist. The active site of an enzyme is usually found in a cleft or pocket that is lined by amino acid residues (or nucleotides in ribozymes) that participates in recognition of the substrate. Residues that directly participate in the catalytic reaction mechanism are called active site residues.

Actual Yield is defined as the quantity of a product found to be formed in a chemical reaction (distinguished from theoretical yield) i.e. the amount of product actually isolated from a reaction. Actual product yields will always be somewhat less than theoretical, due to a variety of application factors.

Adsorption is defined as the adhesion of atoms, ions, biomolecules or molecules of gas, liquid, or dissolved solids to a surface because of chemical or electrical attraction - typically accomplished with granular activated carbon to remove dissolved organics and chlorine. This process creates a film of the adsorbate (the molecules or atoms being accumulated) on the surface of the adsorbent.

Adverse Drug Reaction (ADR) is an expression that describes harm associated with the use of given medications at a normal dose. Adverse events can range from mild to severe. Serious adverse drug reactions are those that can cause disability, are life-threatening, result in hospitalization or death, or are birth defects.

An Allergy is defined as a hypersensitive disorder of the immune system. Allergic reactions occur to normally harmless environmental substances known as allergens; these reactions are acquired, predictable, and rapid. It is characterized by excessive activation of certain white blood cells called mast cells and basophils by a type of antibody known as IgE, resulting in an extreme inflammatory response. Common allergic reactions include eczema, hives, hay fever, asthma attacks, food allergies, and reactions to the venom of stinging insects such as wasps and bees.

Amorphous Materials, also known as soft glasses, deform and flow through a collective movement of their particles. These materials (which include chocolate mousse, shaving cream, mayonnaise, metallic glasses, granular materials and mud) are amorphous solids, in other words, they are resistant like solids but, like liquids, lack a crystalline structure. Colloids, emulsions, window glass, dense polymers, and even biological tissues are some examples.

Amorphous Solids are solids that have a disordered atomic structure. In contrast, solids that exhibit long-range order in the atomic positions are called crystallines or morphous. Most classes of solid materials can be found or prepared in an amorphous form. For instance, common window glass is an amorphous solid, many polymers (such as polystyrene) are amorphous, and even junk foods such as cotton candy are amorphous solids.

Amoxil is a penicillin antibiotic that fights bacteria. Amoxil is used to treat many different types of infection caused by bacteria, such as tonsillitis, bronchitis, pneumonia, and infections of the ear, nose, throat, skin, or urinary tract.

Amoxil is also sometimes used together with another antibiotic called clarithromycin (Biaxin) to treat stomach ulcers caused by Helicobacter pylori infection. This combination is sometimes used with a stomach acid reducer called lansoprazole (Prevacid).

Do not use Amoxil if you are allergic to amoxicillin or to any other penicillin antibiotic, such as ampicillin (Omnipen, Principen), dicloxacillin (Dycill, Dynapen), oxacillin (Bactocill), penicillin (Beepen-VK, Ledercillin VK, Pen-V, Pen-Vee K, Pfizerpen, V-Cillin K, Veetids), and others.

Amoxicillin can make birth control pills less effective.

Anti-Interferon is an antibody to an interferon. It is used for the purification of interferons. The untoward effects of the interferons can be reversed or prevented by simultaneously adding anti-interferon (usually an antibody). This helps in treating many diseases, especially viral infections.

An Antibiotic is defined as an organic substance of microbial origin (usually mold or actinomycete bacteria) that is either toxic or growth inhibiting for other organisms. Also with the advent of synthetic methods of production, a substance produced by a microorganism or a similar substance (produced wholly or partly by chemical synthesis) which, in low concentrations, inhibits the growth of other microorganisms. Penicillin, tetracycline, and erythromycin are examples of antibiotics.

An Antibody is a modified protein molecule present in the blood serum or plasma (and other body fluids), whose activity is associated chiefly with gamma globulin. Produced by the immune system in response to exposure to a foreign substance, it is the body's protective mechanism against infection and disease. An antibody is characterized by a structure complementary to the foreign substance, the antigen that provokes its formation, and is thus capable of binding specifically to the foreign substance to neutralize it.

Antibody Production, for example, is when animals produce antibodies in response to proteins or other molecules (termed immunogens) recognized as foreign by their immune system. The antibodies are secreted into the plasma by B cells that are able to interact with the immunogen. The intensity of the response is determined by several factors including the size of the immunogen molecule, its chemical characteristics, and how different it is from the animal's own proteins. Most natural immunogens are proteins. The antibody response increases with repeated exposure to the immunogen, so a series of injections at regular intervals is needed to achieve both high levels of antibody production and antibodies of high affinity.

An Antigen is defined as any of various foreign substances such as bacteria, viruses, endotoxins, exotoxins, foreign proteins, pollen, and vaccines, whose entry into an organism induces an immune response (antibody production, lymphokine production, or both) directed specifically against that molecule. Response may be demonstrated as an increased reaction, such as hypersensitivity (usually protein or a complex of protein and polysaccharide, or occasionally a polysaccharide of high molecular weight), a circulating antibody that reacts with the antigen, or some degree of immunity to infectious disease if the antigen was a microorganism or its products.

Aseptic Packaging is defined as the filling of a commercially sterile product into a sterile container under aseptic conditions and hermetically sealing the containers so that reinfection is prevented. This results in a product, which is shelf-stable at ambient conditions. The term “aseptic” is derived from the Greek word “septicos” which means the absence of putrefactive micro-organisms.

Assay Development is a procedure in molecular biology for testing or measuring the activity of a drug or biochemical in an organism or organic sample. A quantitative assay may also measure the amount of a substance in a sample. Bioassays and immunoassays are among the many varieties of specialized biochemical assays. Other assays measure processes such as enzyme activity, antigen capture, stem cell activity, and competitive protein binding.

Bacteria are any of a large group of microscopic organisms having round, rod-shaped, spiral, or filamentous unicellular or noncellular bodies that are often aggregated into colonies, are enclosed by a cell wall or membrane (prokaryotes), and lack fully differentiated nuclei. Bacteria range in size from 0.4µm to 2.0µm and may exist as free-living organisms in soil, water, organic matter, or as parasites in the live bodies of plants. Some are disease producing, but most perform necessary functions such as digestion, fermentation, and nitrification. Most of the forms are variously grouped under generic names such as: Alcaligenes, Dialister, Escherichia, Klebsiella, Kurthia, Pasteurella, Salmonella, and Shigella.

A Bacterium is a single celled organism with no nucleus. Typically a few micrometres in length, bacteria have a wide range of shapes, ranging from spheres to rods and spirals.

Behavioural Health, as a general concept, refers to the reciprocal relationship between human behavior, individually or socially, and the well-being of the body, mind, and spirit, whether the latter are considered individually or as an integrated whole. Behavioural Health is more commonly used to describe a field of scientific study, academic proficiency and clinical healthcare practice.

A Bioassay, also called biological standardisation, is a type of scientific experiment. Bioassays are typically conducted to measure the effects of a substance on a living organism and are essential in the development of new drugsand in monitoring environmental pollutants. Both are procedures by which the potency (pharmacology) or the nature of a substance is estimated by studying its effects on living matter.

Bioavailability is used to describe the fraction of an administered dose of unchanged drug that reaches the systemic circulation, one of the principal pharmacokinetic properties of drugs. By definition, when a medication is administered intravenously, its bioavailability is 100%. However, when a medication is administered via other routes (such as orally), its bioavailability decreases (due to incomplete absorption and first-pass metabolism) or may vary from patient to patient (due to inter-individual variation). Bioavailability is one of the essential tools in Pharmacokinetics, as bioavailability must be considered when calculating dosages for non-intravenous routes of administration.

A Biobank is defined as a cryogenic storage facility used to archive biological samples for use in research and experiments collected from clinically-characterised volunteers comprising blood, induced sputum, bronchial biopsies and epithelial cells. These samples are used to develop the complex in vitro human disease models. Biobanks are maintained by institutions such as hospitals, universities, nonprofit organizations, and pharmaceutical companies.

Bioequivalency is a term in pharmacokinetics used to assess the expected in vivo biological equivalence of two proprietary preparations of a drug. If two products are said to be bioequivalent it means that they would be expected to be, for all intents and purposes, the same. It is a scientific basis on which generic and brand name drugs are compared with one another.

A Biohazard is defined as an infectious agent(s), or part thereof, presenting a real or potential risk to human, other animals, or plants, directly through infection or indirectly through disruption of the environment.

Bioinformatics is defined as the science of using computer technology to gather, store, analyze and merge biological data. Expertise in bioinformatics is key to handling the enormous amounts of data produced by the Human Genome Project and other sequencing projects, and serving it out to the researchers who use the data. Advances in computer research are as important as the biology for such large scale projects.

Biological Impurities are defined as impurities resulting from living matter (bacteria, virus, algae, protozoa, microfungi) and their by-products, including pyrogens (endotoxins).

Biological Indicators are defined as resistant microorganisms placed into or on various materials to confirm that a sterilization process is effective. Biological indicators are aquatic plant and animal life that are susceptible to specific types and levels of pollutants. They may for instance be placed within a filter in order to determine if a proposed autoclave cycle is effective. After autoclave, they are removed and culture tests are performed to see if the microorganisms were killed.

Biological Reactivity Tests, In Vivo are designed to determine the biological response of animals to elastomerics, plastics and other polymeric material with direct or indirect patient contact, or by the injection of specific extracts prepared from the material under test. Three tests are described:

1. Systemic Injection Test - Designed to determine the systemic biological responses of animals to plastics and other polymers by the single-dose injection of specific extracts prepared from a sample.

2. Intracutaneous Test - Designed to determine the local biological responses of animals to plastics and other polymers by the single-dose injection of specific extracts prepared from a sample.

3. Implantation Test - Designed to evaluate the reaction of living tissue to the plastic and other polymers by the implantation of the sample (specimen under test) itself into animal tissue.

With the exception of the Implantation Test, the procedures are based on the use of extracts that, depending on the heat resistance of the material, are prepared at one of the three standard temperatures: 50°, 70°, and 121°. Therefore, the class designation of a plastic must be accompanied by an indication of the temperature of extraction e.g., IV - 121°, which represents a class IV plastic extracted at 121°).

Biologics includes a wide range of medicinal products such as vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins created by biological processes. Biologics can be composed of sugars, proteins, or nucleic acids or complex combinations of these substances, or may be living entities such as cells and tissues. Biologics are isolated from a variety of natural sources like human, animal, or microorganism and may be produced by biotechnology methods and other technologies.

Biomanufacturing is defined as an industrial production using scalable, validated processes that use a biological organism, or parts of a biological organism, in an unnatural manner to produce a product, as well as products designed to detect, modify, maintain and study biological organisms for use as new manufacturing agents. This uses living cells as miniature factories.

A Biomarker is defined as anything that can be used as an indicator of a particular disease state or some other biological state of an organism. A biomarker can be a substance that is introduced into an organism as a means to examine organ function or other aspects of health. For example, rubidium chloride is used as a radioactive isotope to evaluate perfusion of heart muscle. It can also be a substance whose detection indicates a particular disease state, for example, the presence of an antibody may indicate an infection. Biomarkers can be specific cells, molecules, or genes, gene products, enzymes, or hormones.

A Biomaterial is defined as a material which is in whole or in part composed of living matter, such as polymer scaffolding perfused with cells. Biomaterials may be used as a medical device which augments or replaces natural tissue for therapeutic effect. The combination of synthetic and living material derived from stem cells could enable the repair of heart valves, bone, cartilage and other tissues by replacing or patching the damaged parts with materials that are genetically identical to the patient, and therefore safe from immunological rejection.

Biometrics are defined as methods for uniquely recognising humans based upon one or more intrinsic physical or behavioral traits. In computer science, in particular, biometrics are used as a form of identity access management and access control. Biometrics are also used to identify individuals in groups that are under surveillance.

Biopatents, also referred to as patents of life, are defined as patents of living organisms that can include plant and animal species, and related biological and biotechnology-enabled inventions. These are patents on living things. They are an extreme form of control over life as they give total ownership of a patented organism for 20 years.

Biopharmaceuticals, also referred to as The Biopharma Industry, is the industry where ethical pharmaceutical drugs are derived through bioprocessing. They are proteins (including antibodies), nucleic acids (DNA, RNA or antisense oligonucleotides) used for therapeutic or in vivo diagnostic purposes, and are produced by means other than direct extraction from a native (non-engineered) biological source. The first such substance approved for therapeutic use was biosynthetic 'human' insulin made via recombinant DNA technology.

Bioprocess Engineering is defined as the process that uses complete living cells or their components (e.g., enzymes, chloroplasts) to effect desired physical or chemical changes. Bioprocess Engineering deals with the design and development of equipment and processes for the manufacturing of products such as food, feed, pharmaceuticals, nutraceuticals, chemicals, and polymers and paper from biological materials.

Bioprocessing is defined as any process that uses complete living cells or their components (e.g., bacteria, enzymes, chloroplasts) to obtain desired products. Bioprocessing is also key to several emerging industries and technologies, including the production of renewable biofuels such as ethanol and biodiesel, therapeutic stem cells, gene therapy vectors, and new vaccines. The Food and Drug Administration imposes stringent regulations on bioprocessing in the biotech industry; this highly regulated environment has an enormous impact on plant operations and product manufacture.

A Bioreactor is defined as a closed system used for bioprocessing (flask, roller bottle, tank, vessel, or other container), which supports the growth of cells, mammalian or bacterial, in a culture medium. A bacterial reaction usually is said to take place in a fermenter, and cell culture in a bioreactor.

Biosimilars, also referred to as Follow-on Biologics, is a term used to describe officially-approved subsequent versions of innovator biopharmaceutical products made by a different sponsor following patent and exclusivity expiry on the innovator product. Biosimilars are also referred to as subsequent entry biologics (SEBs) in Canada. Similar biological medicinal products are often called biosimilars.

Biosynthesis, also referred to as biogenesis, is an enzyme-catalyzed process in cells of living organisms by which substrates are converted to more complex products. The biosynthesis process often consists of several enzymatic steps in which the product of one step is used as substrate in the following step. Examples for such multi-step biosynthetic pathways are those for the production of amino acids, fatty acids, and natural products. Biosynthesis plays a major role in all cells, and many dedicated metabolic routes combined constitute general metabolism.

Biotech Blogs, or biotechnology blogs, are designed for people working in the pharmaceutical and biotechnology industries. These blogs include technical articles, articles on companies in the industry, information on potential collaborations, and alliances and employment opportunities and also provide commercial, legal, political and scientific trends in biotechnology.

Biotechnology Definition: Biotechnology is a field of applied biology that involves the use of living organisms and bioprocesses in engineering, technology, medicine and other fields requiring bioproducts. In modern use, similar terms include genetic engineering as well as cell- and tissue culture technologies. The concept encompasses a wide range of procedures (and history) for modifying living organisms according to human purposes - going back to domestication of animals, cultivation of plants, and "improvements" to these through breeding programs that employ artificial selection and hybridisation. By comparison to biotechnology, bioengineering is generally thought of as a related field with its emphasis more on higher systems approaches (not necessarily altering or using biological materials directly) for interfacing with and utilising living things.

Bisoprolol is a beta-blocker that affects the heart and circulation (blood flow through arteries and veins). Bisoprolol is used to treat hypertension (high blood pressure). Bisoprolol may also be used for purposes not listed in this medication guide.

Do not skip doses or stop taking bisoprolol without first talking to your doctor. Stopping suddenly may make your condition worse or cause other serious heart problems. If you need to have any type of surgery, tell the surgeon ahead of time that you are using this medicine. You should not use bisoprolol if you have a serious heart condition such as "AV block," severe heart failure, or slow heartbeats that have caused you to faint.

Keep using bisoprolol as directed, even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your life.

Bulk Handling is defined as the transferring of flammable or combustible liquids from tanks or drums into smaller containers for distribution. Solid, free-flowing materials are said to be in bulk. The handling of these materials requires that the machinery both support their weight and confine them either to a desired path of travel for continuous conveyance or within a container for handling in discrete loads. Wet or sticky materials may also be handled successfully by some of the same machines used for bulk materials. Characteristics of materials that affect the selection of equipment for bulk handling include (1) the size of component particles, (2) flowability, (3) abrasiveness, (4) corrosiveness, (5) sensitivity to contamination, and (6) general conditions such as dampness, structure, or the presence of dust or noxious fumes.

Bulk Pharmaceutical Chemical (BPC) is defined as a pharmaceutical product derived by chemical synthesis, in bulk form, for later dispensing, formulation or compounding, and filling in a pharmaceutical finishing facility.

Calorimetry is defined as an analytical method that measures heat loss or gain resulting from physical or chemical changes in a sample. Differential scanning calorimetry compares the results of heating a sample to those for heating a reference material. For example, a method to measure the temperature at which the sample crystallizes, changes phases, or decomposes.

Capsule Banding is defined as sealing of capsules filled with liquids, powders or other products. It is done to seal the joint between the capsule cap and body in order to prevent leakage of liquid products; reduce oxidation of the contents of the capsule; and to minimize the odor problems associated with both solid and liquid products. Once banded, the capsule is almost impossible to open and re-close without leaving evidence of tampering.

Carcinogenicity, or a carcinogen, is any substance, radionuclide or radiation, that is an agent directly involved in causing cancer. This may be due to the ability to damage the genome or to the disruption of cellular metabolic processes. Several radioactive substances are considered carcinogens, but their carcinogenic activity is attributed to the radiation, for example gamma rays and alpha particles, which they emit. Carcinogenicity of radiation depends of the type of radiation, type of exposure, and penetration.

Cardiology is the branch of medicine dealing with the structure, function and disorders of the heart. Cardiology includes diagnosis and treatment of congenital heart defects, coronary artery disease, heart failure, valvular heart disease and electrophysiology.

Cell Culture refers the complex process by which cells are grown under controlled conditions. In practice, the term "cell culture" has come to refer to the culturing of cells derived from multicellular eukaryotes, especially animal cells. The historical development and methods of cell culture are closely interrelated to those of tissue culture and organ culture. There are also cultures of plants, fungi and microbes, including viruses, bacteria and protists.

Cell Lines are defined as a permanently established cell culture that will proliferate indefinitely given appropriate fresh medium and space. Some species, particularly rodents, give rise to cell lines relatively easily, whereas other species do not. No cell lines have been produced from avian tissues and the establishment of cell lines from human tissue is difficult.

Centrifugation is a process that involves the use of the centrifugal force for the separation of mixtures, used in industry and in laboratory settings. More-dense components of the mixture migrate away from the axis of the centrifuge, while less-dense components of the mixture migrate towards the axis. Chemists and biologists may increase the effective gravitational force on a test tube so as to more rapidly and completely cause the precipitate ("pellet") to gather on the bottom of the tube. The remaining solution is properly called the "supernate" or "supernatant liquid". The supernatant liquid is then either quickly decanted from the tube without disturbing the precipitate, or withdrawn with a Pasteur pipette. The rate of centrifugation is specified by the acceleration applied to the sample, typically measured in revolutions per minute (RPM).

A centrifuge operates on the principle of centrifugal force, the inertial reaction by which a body tends to move away from a center about which it revolves. This technique is commonly used to separate solids from liquids or liquids of different densities. Centrifugal equipment is divided into two major types, sedimenters and filters.

A Chief Medical Officer (CMO) is a qualified medical doctor whose specialty is in public health and in the health of communities, rather than health of individuals. The CMO is one of the six chief professional officers, one for each of six professions, who advise the government in their respective specialty.

Chromatography is the collective term for a set of laboratory techniques for the separation of mixtures. Chromatography involves passing a mixture dissolved in a "mobile phase" through a stationary phase, which separates the analyte to be measured from other molecules in the mixture based on differential partitioning between the mobile and stationary phases. Chromatography may be preparative or analytical. The purpose of preparative chromatography is to separate the components of a mixture for further use (and is thus a form of purification). Analytical chromatography is done normally with smaller amounts of material and is for measuring the relative proportions of analytes in a mixture.

Ciprofloxacin is a fluoroquinolone (flor-o-KWIN-o-lone) antibiotic, it is used to treat different types of bacterial infections. It is also used to treat people who have been exposed to anthrax or certain types of plague. Ciprofloxacin extended-release is only approved for use in adults. Fluoroquinolone antibiotics can cause serious or disabling side effects that may not be reversible. Ciprofloxacin should be used only for infections that cannot be treated with a safer antibiotic.

Ciprofloxacin can cause serious side effects, including tendon problems, nerve damage, serious mood or behavior changes, or low blood sugar.

Stop using ciprofloxacin and call your doctor at once if you have: headache, hunger, irritability, numbness, tingling, burning pain, confusion, agitation, paranoia, problems with memory or concentration, thoughts of suicide, or sudden pain or movement problems in any of your joints.

In rare cases, ciprofloxacin may cause damage to your aorta, which could lead to dangerous bleeding or death. Get emergency medical help if you have severe and constant pain in your chest, stomach, or back. You may not be able to use this medicine if you have a muscle disorder. Tell your doctor if you have a history of myasthenia gravis

A Cleanroom is defined as an environment, typically used in manufacturing or scientific research that has a low level of environmental pollutants such as dust, airborne microbes, aerosol particles and chemical vapors. More accurately, a clean room has a controlled level of contamination that is specified by the number of particles per cubic meter at a specified particle size.

Clinical Data Management (CDM), or Clinical Data Management System (CDMS), is used in clinical research to manage the data of a clinical trial. The clinical trial data gathered at the investigator site in the case report form are stored in the CDMS. To reduce the possibility of errors due to human entry, the systems employ different means to verify the entry. The most popular method is double data entry. Once the data has been screened for typographical errors, the data can be validated to check for logical errors. Another function that the CDMS can perform is the coding of data. Currently, the coding is generally centered on two areas; adverse event terms and medication names.

A Clinical Design is defined as the formulation of trials and experiments in medical and epidemiological research, known as clinical trials. The strongest experimental design (the "gold standard") is the randomized design in which subjects (patients) are randomly assigned to treatment groups.

Clinical Development, also called Drug Development, is a blanket term used to define the entire process of bringing a new drug or device to the market. It includes drug discovery / product development, pre-clinical research (microorganisms/animals) and clinical trials (on humans). Few people still refer to the drug development as mere preclinical development.

Clinical Outsourcing is an alternative to keeping the process in-house. Clinical Outsourcing has long been a popular cost saving measure but now, more than ever, sponsors need to see real returns on their investment. The measures of success in outsourcing are clear – quicker, more cost efficient clinical trials that deliver results on time and on budget.

Clinical Research is a branch of medical science that determines the safety and effectiveness of medications, devices, diagnostic products and treatment regimens intended for human use. These may be used for prevention, treatment, diagnosis or for relieving symptoms of a disease. The term clinical research refers to the entire biography of a drug from its inception in the lab to its introduction to the consumer market and beyond. Once the promising candidate or the molecule is identified in the lab, it is subjected to pre-clinical studies or animal studies where different aspects of the drug (including its efficacy and toxicity) are studied.

A Clinical Research Coordinator (CRC) is responsible for conducting clinical trials using good clinical practice (GCP) under the auspices of the Principal Investigator (PI). The CRC’s primary responsibility is the protection of human subjects, and other responsibilities include preparing the Institutional Review Board submission, writing the informed consent document, working with the institutional official in contract negotiations , developing a detailed cost analysis, negotiating the budget with the Sponsor (i.e. pharmaceutical company or granting agency), subject recruitment, patient care, adverse event reporting, preparing the case report form (CRF), submitting CRFs and other data to the Sponsor as necessary and study close-out.

Clinical Supply, or Clinical Trial Supply, is defined as the supply of materials required for conducting a clinical trial and this includes 24-hour collection and delivery of biological specimens (including infectious samples), investigational drugs, kits and other study materials and supplies, expertise/assistance with all permit applications including import permits, Ministry of Health authorizations, etc., customs clearance including pre-clearance whenever possible to ensure the fastest possible delivery, cold chain services including temperature-controlled packaging, supplies and expertise.

A Clinical Supply Chain is the chain from raw materials right through to world-wide distribution to customers (the patient). The core of any good clinical supply chain system is a supply management system that addresses all of the nuances of clinical supplies. There are many processes of a clinical supply chain which can be accomplished internally. The key business units engaged with clinical supplies activities include: manufacturing, packaging, pharmacy, quality, regulatory, clinical and analytics.

A clinical trial, also called a clinical study or a medical trial, is conducted to allow safety and efficacy data to be collected for health interventions (e.g., drugs, diagnostics, devices, therapy protocols). These trials can take place only after satisfactory information has been gathered on the quality of the non-clinical safety, and Health Authority/Ethics Committee approval is granted in the country where the trial is taking place. Depending on the type of product and the stage of its development, investigators enrol healthy volunteers and/or patients into small pilot studies initially, followed by larger scale studies in patients that often compare the new product with the currently prescribed treatment. As positive safety and efficacy data are gathered, the number of patients is typically increased. Clinical trials can vary in size from a single center in one country to multicenter trials in multiple countries.

Co-Crystals are defined as a technology used to enhance solubility, stability and the IP position with respect to the development of active pharmaceutical ingredients (APIs). Exploring the co-crystallization potential around an API increases the intellectual property protection over a particular drug product; thus, reducing the risk of costly litigation and market erosion.

Coating Systems are extensively used by pharmaceutical companies for coating solid oral dosage forms to protect against deterioration by environmental factors like sunlight, temperature variations, moisture, environmental gases etc., to facilitate swallowing, to mask taste and odor, to increase shelf-life, to enhance aesthetic appeal and brand image, to facilitate product identification during manufacture and prevent wastage during packing and handling, to provide immediate release, specific release, sustained release, controlled release and targeted drug delivery properties, to provide enteric release properties for release in the intestinal tract and to facilitate identification of oncological drugs.

A cold chain, also referred to as cool chain, is a supply chain with cargo that undergoes end-to-end temperature control through transit. An unbroken cold chain is a sequence of storage efforts that maintain a given temperature range (usually within the bracket of 2 – 8 degrees) to transport a sensitive product, including the likes of pharmaceutical drugs and biological materials.

Complementary DNA (cDNA) is DNA synthesized from a mature mRNA template in a reaction catalyzed by the enzyme reverse transcriptase and the enzyme DNA polymerase. cDNA is often used to clone eukaryotic genes in prokaryotes. When scientists want to express a specific protein in a cell that does not normally express that protein (i.e., heterologous expression), they will transfer the cDNA that codes for the protein to the recipient cell. cDNA is also produced by retroviruses (such as HIV-1, HIV-2, Simian Immunodeficiency Virus, etc.) which is integrated into its host to create a provirus.

Compound Libraries are defined as the collections of compounds that provide a variety of chemically diverse structures that can be used to identify structure types that have affinity with pharmacological targets. The compounds include pure natural compounds, synthetic compounds and synthetically modified pure natural compounds.

Compound Management, also referred to as Compound Control, is defined as the management of chemical libraries, including renewal of outdated chemicals, databases containing the information, robotics often involved in fetching chemicals, and quality control of the storage environment. Compound Management is often a significant expense, as well as career for one or more individuals who manage a chemical library at a research site.

Compound Screening is defined as the identification of compounds that could be promising candidates for drug development, before it advances to the more-costly stages of preclinical and clinical trials. Compound Screening is also done to identify the potential side effects caused by administration of such compound(s).

Containment is defined as the action of confining within a defined space a microbiological agent or other entity that is being cultured, stored, manipulated, transported, or destroyed in order to prevent or limit its contact with people and/or the environment. Methods to achieve containment include physical and biological barriers and inactivation using physical or chemical means.

Contamination is defined as the undesired introduction of impurities of a chemical or microbiological nature, or of foreign matter, into or onto a raw material, intermediate, or API (Active Pharmaceutical Ingredient) during production, sampling, packaging or repackaging, storage or transport.

Contract Manufacturing (CM) is defined as a firm that manufactures components or products for another "hiring" firm. It is a form of outsourcing. The practice of utilizing contract manufacturing relies on the manufacturer's ability to drive down the cost of production through economies of scale. It also allows the hiring company to obtain the needed components or products without needing to own and operate a factory. Many industries utilize this process, especially the aerospace, defense, computer, semiconductor, energy, medical, food manufacturing, personal care, and automotive fields.

Contract Packaging is a firm that performs all packaging functions from the simplest to the most complex and from the glamorous to the hazardous. Packaging service ranges from manual and semi-automatic to full-speed, high performance packaging lines. Other services include design, warehousing, distribution and other business services. The objectives include programs to establish strong ethical standards among contract packagers and their clients, to increase knowledge and expertise within the contract packaging industry, to improve the business reputation of firms and the professional image of individuals within the industry, and to encourage the effective use of contract packaging services.

A Contract Research Organisation, also called Clinical Research Organization (CRO) is a service organization that provides support to the pharmaceutical and biotechnology industries in the form of outsourced pharmaceutical research services (for both drugs and medical devices). CROs range from large, international full service organizations to small, niche specialty groups and can offer their clients the experience of moving a new drug or device from its conception to FDA marketing approval without the drug sponsor having to maintain a staff for these services.

Crystallisation (Crystallization) is defined as a unit operation through which a chemical compound, dissolved in a given solvent, precipitates under certain conditions to allow successive separation between the phases. Crystallization is therefore an aspect of precipitation, obtained through a variation of the solubility conditions of the solute in the solvent, as compared to precipitation due to chemical reaction.

Current Good Manufacturing Practices (cGMPs) are the current accepted standards of design, operation, practice, and sanitization. These are the standard guidelines set out by the FDA to ensure drug development is carried out in safe and quality processes, to avoid contamination and ensure repeatability. The FDA is empowered to inspect drug-manufacturing plants in which drugs are processed, manufactured, packaged, and stored for compliance with these standards.

Cytotoxic is a term that refers to a compound that results in a variety of cell fates. The cells may undergo necrosis, in which they lose membrane integrity and die rapidly as a result of cell lysis. The cells can stop actively growing and dividing (a decrease in cell viability), or the cells can activate a genetic program of controlled cell death (apoptosis). Examples of toxic agents are a chemical substance, an immune cell or some types of venom (e.g. from the puff adder or brown recluse spider).

Cytotoxicity is defined as the quality of being toxic to cells. Cytotoxicity assays are widely used by the pharmaceutical industry to screen for cytotoxicity in compound libraries. Antibody-dependent cell-mediated cytotoxicity (ADCC) describes the cell-killing ability of certain lymphocytes, which requires the target cell being marked by an antibody. Lymphocyte-mediated cytotoxicity, on the other hand, does not have to be mediated by antibodies; nor does complement-dependent cytotoxicity (CDC), which is mediated by the complement system.

Data Integrity is defined as that data that has a complete or whole structure or in other terms the validity of data and their relationships. All characteristics of the data including business rules, rules for how pieces of data relate dates, definitions and lineage must be correct for data to be complete. For electronic records to be trustworthy and reliable, the links between raw data, metadata, and results must not be compromised or broken. Without data integrity, it is not possible to regenerate a previous result reliably.

Data Migration is defined as the process of translating data from one system to another when a company replaces the current computing systems with a new one. Data migration phases (design, extraction, cleansing, load, verification) for applications of moderate to high complexity are commonly repeated several times before the new system is deployed.

Dentistry is the branch of medicine that is involved in the evaluation, diagnosis, prevention, and surgical or non-surgical treatment of diseases, disorders and conditions of the oral cavity, maxillofacial area and the adjacent and associated structures and their impact on the human body. Dentistry is widely considered necessary for complete overall health.

Dermatology is the branch of medicine dealing with the structure, function and diseases of skin, a unique specialty with both medical and surgical aspects. Problems include warts, hair loss, fungal infections, acne, athlete's foot, eczema, rashes and skin cancer. A dermatologist takes care of diseases, in the widest sense, and some cosmetic problems of the skin, scalp, hair, and nails.

Diflucan is an oral (taken by mouth) antifungal medicine. Diflucan is available as a tablet or as an oral suspension (liquid). Diflucan is used to treat infections caused by fungus, which can invade any part of the body including the mouth, throat, esophagus, lungs, bladder, genital area, and the blood. Diflucan is also used to prevent fungal infection in people who have a weak immune system caused by cancer treatment, bone marrow transplant, or diseases such as AIDS.

Diflucan is also used to treat a certain type of meningitis in people with HIV or AIDS. Certain other drugs can cause unwanted or dangerous effects when used with Diflucan,especially cisapride, erythromycin, pimozide, quinidine, astemizole, higher doses of terfenadine, and many other medications that are broken down by certain enzymes that are inhibited by fluconazole. Tell each of your healthcare providers about all medicines you use now, and any medicine you start or stop using.

Before taking Diflucan, tell your doctor if you have liver disease, kidney disease, a heart rhythm disorder, or a history of Long QT syndrome. Take this medicine for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antifungal medication. Fluconazole will not treat a viral infection such as the common cold or flu.

Disposable Medical Supplies is a firm that supplies disposable medical and lab consumables such as disposable infusion sets, blood transfusion sets, vaginal speculum, urinary swab, endometrial suction curette, cervical spatula, various catheters, syringe sets etc. Disposable Medical Supplies are designed to minimize patient discomfort and distress.

Dissolution Testing is defined as a critical formulation tool in the process of drug discovery that entails measuring the stability of the investigational product, achieving uniformity in production lots and determining its in vivo availability. The Dissolution Testing method is useful in the pharmaceutical and biotechnology industry to formulate drug dosage forms and to develop quality control specifications for its manufacturing process.

Distillation is defined as a method of separating mixtures based on differences in their volatilities in a boiling liquid mixture. Distillation is a unit operation, or a physical separation process, and not a chemical reaction. It is used to separate crude oil into more fractions for specific uses such as transport, power generation and heating. Water is distilled to remove impurities, such as salt from seawater. Air is distilled to separate its components—notably oxygen, nitrogen, and argon—for industrial use. Distillation of fermented solutions has been used since ancient times to produce distilled beverages with higher alcohol content. The premises where distillation is carried out, especially distillation of alcohol are known as a distillery.

DNA (Deoxyribonucleic Acid) is the molecular basis for genes; every inherited characteristic has its origin somewhere in the code of the organism's complement of DNA. The code is made up of subunits, nucleic acids. The organism to produce the required proteins that compose the genetic traits of the organism and its life functions interprets the sequence of the four nucleic acids.

A DNA Array is defined as a multiplex technology used in molecular biology. It consists of an arrayed series of thousands of microscopic spots of DNA oligonucleotides, called features, each containing picomoles (10-12 moles) of a specific DNA sequence, known as probes (or reporters). DNA arrays can be used to measure changes in expression levels, to detect single nucleotide polymorphisms (SNPs), or to genotype or resequence mutant genomes.

A DNA Sequence is defined as the relative order of base pairs, whether in a fragment of DNA, a gene, a chromosome, or an entire genome. The DNA sequence has capacity to carry information which directs the functions of living beings, the term genetic sequence is often used. Sequences can be read from the biological raw material through DNA sequencing methods.

DNA Sequencing refers to sequencing methods for determining the order of the nucleotide bases—adenine, guanine, cytosine, and thymine—in a molecule of DNA. Two common methods available are The Maxam Gilbert technique, which uses chemicals to cleave DNA into fragments at specific bases; or, most commonly, the Sanger technique (also called the di-deoxy or chain-terminating method) which uses DNA polymerase to make new DNA chains, in the presence of di-deoxynucleotides (chain terminators) to stop the chain randomly as it grows. In both cases, the DNA fragments are separated according to length by polyacrylamide gel electrophoresis, enabling the sequence to be read directly from the gel.

Dosage Form (DF) is defined as the physical form of a dose of a chemical compound used as a drug or medication intended for administration or consumption. Common dosage forms include pill, tablet, or capsule, drink or syrup, aerosol or inhaler, liquid injection, pure powder or solid crystal (e.g., via oral ingestion or freebase smoking), and natural or herbal form such as plant or food of sorts, among many others. The route of administration (ROA) for drug delivery is dependent on the dosage form of the substance.

A Dosage Group is defined as a group of subjects in a clinical trial receiving the same or different dosages (amount) of a drug being tested. For example out of 100 congestive heart failure patients, Group A (n=50) receives 50mg/day and Group B (n=50) receives 150 mg/day of losartan.

Downstream Processing refers to the recovery and purification of biosynthetic products, particularly pharmaceuticals, from natural sources such as animal or plant tissue or fermentation broth, including the recycling of salvageable components and the proper treatment and disposal of waste. It is an essential step in the manufacture of pharmaceuticals such as antibiotics, hormones (e.g. insulin and human growth hormone), antibodies (e.g. infliximab and abciximab) and vaccines; antibodies and enzymes used in diagnostics; industrial enzymes; and natural fragrance and flavor compounds. Downstream processing is usually considered a specialized field in biochemical engineering.

Drug Delivery is the method or process of administering a pharmaceutical compound to achieve a therapeutic effect in humans or animals. Drug delivery technologies are patent protected formulation technologies that modify drug release profile, absorption, distribution and elimination for the benefit of improving product efficacy and safety, as well as patient convenience and compliance. Most common routes of administration include the preferred non-invasive peroral (through the mouth), topical (skin), transmucosal (nasal, buccal/sublingual, vaginal, ocular and rectal) and inhalation routes.

Drug Delivery Systems are used to deploy medications intact to specifically targeted parts of the body through a medium that can control the therapy’s administration by means of either a physiological or chemical trigger. During the past decade, polymeric microspheres, polymer micelles, and hydrogel-type materials have all been shown to be effective in enhancing drug targeting specificity, lowering systemic drug toxicity, improving treatment absorption rates, and providing protection for pharmaceuticals against biochemical degradation. In addition, several other experimental drug delivery systems show exciting signs of promise, including those composed of biodegradable polymers, dendrimers (so-called star polymers), electroactive polymers, and modified C-60 fullerenes (also known as “buckyballs”).

Drug Development Process is a precarious pharmaceutical business with risks outweighing benefits. Though risky, many major pharmaceutical companies are involved in drug development process, as it is essential for the survival of pharmaceutical companies and for the betterment of people with newer therapy for treating diseases that afflict millions of people worldwide. The full drug development process is a lengthy and complicated one taking ten to twelve years. The cost of developing a new drug is over €800 million, about 60% of which is spent on necessary rigorous clinical trials.

Drug Discovery is defined as the process by which drugs are discovered and/or designed. The process of drug discovery involves the identification of candidates, synthesis, characterization, screening, and assays for therapeutic efficacy. Once a compound has shown its value in these tests, it will begin the process of drug development prior to clinical trials. Despite advances in technology and understanding of biological systems, drug discovery is still a lengthy, "expensive, difficult, and inefficient process" with low rate of new therapeutic discovery.

Drug Manufacturing is defined as the process of industrial-scale synthesis of pharmaceutical drugs by pharmaceutical companies. Drug manufacturing services are characterized by a core commitment to meeting the client’s objectives with the highest quality while maintaining the most efficient use of time and controlling costs.

Drug Regulatory Affairs refers to all aspects within the pharmaceutical development process and how they are subject to various degrees of regulation. The pharmaceutical law frame, guidelines covering Quality, Safety and Efficacy as well as Health Authorities' attitudes and requirements etc. have a great influence on the drug development process and the success of it. Regulatory affairs professionals deal with these aspects.

A Drug Target is defined as a tiny molecule that is involved in some sort of process in a human cell. The process it is involved with can be anything from metabolic (having to do with metabolism) to signaling (taking a chemical signal and turning it into a physical response). Drug targets are specific to a disease condition, like the destruction of the myelin sheath with multiple sclerosis. Other drug targets are disease specific proteins, receptors, enzymes, genes, etc.

Dry Heat Sterilisation is a sterilization method utilizing a heat oven or continuous tunnel (gas or electric heated), as opposed to steam sterilization in an autoclave, usually used for glassware and metal parts. In depyrogenation temperatures of 250ºC result in sterilization and the inactivation of endotoxin present on the surface of the equipment.

Efficacy, or intrinsic activity (IA), is defined as the relative ability of a drug-receptor complex to produce a maximum functional response. This use of the word "efficacy" was introduced by Stephenson (1956) to describe the way in which agonists vary in the response they produce, even when they occupy the same number of receptors. High efficacy agonists can produce the maximal response of the receptor system while occupying a relatively low proportion of the receptors in that system.

An Elastomer is defined as a long chain co-polymers or terpolymers (two or three different monomers in one chain) that contain adequate crosslinks among individual chains. Fluorinated elastomers are more stable than hydrocarbon or silicon elastomers because C-F bonds are approximately 30% stronger than C-H bonds. There are five major FDA compliant elastomers used in the pharmaceutical and biopharmaceutical industries: EPDM (ethylene-propylene-diene rubber), fluororelastomers (FKM), platinum-cured silicon (pt-Si), and finally Kalrez® parts using compounds KLR-6221 and KLR-6230, which are perfluoroelastomers.

Electronic Common Technical Document (eCTD) is a message specification for the transfer of files and metadata from a submitter to a receiver. The content is based on the Common Technical Document (CTD) format. It was developed by the International Conference on Harmonization (ICH) Multidisciplinary Group 2 Expert Working Group (ICH M2 EWG). The eCTD has five modules: Administrative Information and Prescribing Information, Common Technical Document Summaries, Quality, Nonclinical Study Reports and Clinical Study Reports.

An Electronic Laboratory Notebook (ELN), also referred to as an electronic lab notebook, is a software program designed to replace paper laboratory notebooks. Lab notebooks in general are used by scientists and technicians to document research, experiments and procedures performed in a laboratory. ELNs can be divided into two categories: “Specific ELNs" contain features designed to work with specific applications, scientific instrumentation or data types and "Cross-disciplinary ELNs" or "Generic ELNs" are designed to support access to all data and information that needs to be recorded in a lab notebook.

An Electronic Record is defined as any combination of text, graphics, data, audio, pictorial, or other information representation in digital form that is created, modified, maintained, archived, retrieved, or distributed by a computer system. Electronic record contains machine-readable rather than human-readable information.

An Electronic Signature (e-sig) is defined as a computer data compilation of any symbol or series of symbols executed, adopted, or authorized by an individual to be the legally binding equivalent of the individual's handwritten signature. It may be an electronic transmission of the document which contains the signature, as in the case of facsimile transmissions, or it may be encoded message, such as telegraphy using morse code.

Electrophoresis is defined as the migration of electrically charged proteins, colloids, molecules, or other particles when dissolved or suspended in an electrolyte through which an electric current is passed. The most important use of electrophoresis is in the analysis of blood proteins. Since the proportion of these proteins varies widely in different diseases, electrophoresis can be used for diagnostic purposes. Electrophoresis is used to study bacteria and viruses, nucleic acids, and some types of smaller molecules, including amino acids.

Enzyme Linked Immunosorbent Assay (ELISA) is defined as an assay that relies on an enzymatic conversion reaction and is used to detect the presence of specific substances (such as enzymes or viruses or antibodies or bacteria). During the procedure the test material or sample is exposed to a complex of an enzyme linked to an antibody specific to the disease or substance being tested for; when the enzyme and the antigen-antibody complex bind, a color indicator or other easily recognizable sign occurs.

Emergency Medicine is defined as a medical specialty in which a physician receives practical training to care for patients with acute illnesses or injuries which require immediate medical attention. While not usually providing long-term or continuing care, emergency medicine physicians diagnose a variety of illnesses and undertake acute interventions to stabilize the patient. Emergency medicine has evolved to treat conditions that pose a threat to life, limb, or have a significant risk of morbidity.

Enamine is defined as an unsaturated compound derived by the reaction of an aldehyde or ketone with a secondary amine followed by loss of H₂O. The word "enamine" is derived from the affix en-, used as the suffix of alkene, and the root amine. Enamines are both good nucleophiles and good bases.

Endocrinology is the branch of medicine that deals with the hormone-secreting glands (ex: thyroid, pituitary, adrenal, pancreas, ovaries, testes, etc.); also deals with diabetes. Endocrinology refers to the endocrine system - a collection of hormone-producing glands which regulate the body's rate of metabolism, growth and reproductive development and functioning. An increase or decrease in production interferes with the process it controls. Examples of problems include thyroid conditions and diabetes.

An Endotoxin is defined as a poisonous complex molecule (lipopolysaccharide) that forms an integral part of the bacterial (gram-negative bacteria) cell wall and is only released when the integrity of the wall is disturbed. Certain organisms may release endotoxins (e.g. E. coli) during biosynthesis of a recombinant DNA product, thus necessitating purification steps to ensure their removal. In water treatment, it most often refers to pyrogens.

An Endpoint is defined as the point at which an experimental animal's pain and/or distress is terminated, minimized or reduced by taking actions such as humanely killing the animal, terminating a painful procedure, or giving treatment to relieve pain and/or distress.

An Enzyme is defined as any of numerous proteins or conjugated proteins produced by living organisms and functioning as complex biochemical catalysts. They not only promote reactions but also function as regulators making sure the organism do not produce too much or too little of any chemical substance. Although all enzymes are proteins, many contain additional non-protein components essential for catalytic activity. Such enzymes are termed haloenzymes. The protein part of this enzyme is termed an apoenzyme and the non-amino acid part is termed a coenzyme.

Erythromycin belongs to a group of drugs called macrolide antibiotics. Macrolide antibiotics slow the growth of, or sometimes kill, sensitive bacteria by reducing the production of important proteins needed by the bacteria to survive.

Erythromycin is used to treat or prevent many different types of infections caused by bacteria. Erythromycin may also be used for purposes.Some medicines can cause unwanted or dangerous effects when used with erythromycin.

Your doctor may need to change your treatment plan if you use cisapride, pimozide, ergotamine, or dihydroergotamine. Before you take erythromycin, tell your doctor if you have liver disease, myasthenia gravis, a heart rhythm disorder, a history of Long QT syndrome, or low levels of potassium or magnesium in your blood. Take this medicine for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antibiotics.

Erythromycin will not treat a viral infection such as the common cold or flu. Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, stop taking erythromycin and call your doctor. Do not use anti-diarrhea medicine unless your doctor tells you to.

Ethical Pharmaceuticals or ethics involving pharmaceuticals, are built from the organizational ethics stemming from a drug manufacturer - system compliance, accountability and culture. The ethics formed are based on legal requirements from regulatory boards. The law however should be seen as a minimum standard and a higher ethical standard should be demanded; from pharmaceutical companies have seen these demands by both agency and public demand across the world. It is a controlled substance for the diagnosis or treatment of disease.

European Medicines Evaluation Agency (EMEA) or European Medicines Agency (EMA) is a European agency for the evaluation of medicinal products. From 1995 to 2004, the European Medicines Agency was known as European Agency for the Evaluation of Medicinal Products. The EMA was set up in 1995 with funding from the European Union and the pharmaceutical industry, as well as indirect subsidy from member states, in an attempt to harmonize (but not replace) the work of existing national medicine regulatory bodies.

An Excipient is defined as a more or less inert substance added in a prescription drug compound as a diluent or vehicle or to give form or consistency when the remedy is given in a pill form; simple syrup, aromatic powder, honey, and various elixirs are examples of excipients.

Famotidine is a histamine-2 blocker that works by decreasing the amount of acid the stomach produces. Famotidine is used to treat and prevent ulcers in the stomach and intestines. It also treats conditions in which the stomach produces too much acid, such as Zollinger-Ellison syndrome.

Famotidine also treats gastroesophageal reflux disease (GERD) and other conditions in which acid backs up from the stomach into the esophagus, causing heartburn.

Before taking famotidine, tell your doctor if you have kidney or liver disease, a history of Long QT syndrome, stomach cancer or other problems, or asthma, COPD, or other breathing problems. Famotidine may be only part of a complete program of treatment that also includes changes in diet or lifestyle habits.

Follow your doctor's instructions very closely. Heartburn is often confused with the first symptoms of a heart attack. Seek emergency medical attention if you have chest pain or heavy feeling, pain spreading to the jaw, arm or shoulder, nausea, sweating, anxiety, light-headedness and a general ill feeling.

FDA Approval refers to the list of drugs approved by the Food and Drug Administration (FDA) for sale in the United States. New drugs receive extensive scrutiny before FDA approval in a process called a New Drug Application or NDA. After approval of an NDA, the sponsor must review and report to the FDA every patient adverse drug experience of which it learns. Unexpected serious and fatal adverse drug events must be reported within 15 days; other events on a quarterly basis. As a condition of approval, a sponsor may be required to conduct additional clinical trials, called Phase IV trials.

FDA Compliance refers to conforming to a rule, such as a specification, policy, standard or law stated by U.S. FDA. Regulatory compliance describes the goal that corporations or public agencies aspire to in their efforts to ensure that personnel are aware of and take steps to comply with relevant laws and regulations.

Fermentation is defined as the biochemical synthesis of organic compounds by microorganisms. It is the process of growing microorganisms within an enclosed tank (fermenter) under controlled conditions of aeration, agitation, temperature, and pH. The different types organisms used as a basis for fermentation are: bacteria (E. coli), yeasts, molds, Chinese Hamster Ovary (CHO) cells, kidney cells and vaccines to viruses.

Fill and Finish (Parenteral Drugs) refers to preparation of parenteral drugs, either LVPs or SVPs, which demand the highest level of contamination control, because the human body's normal defenses against infection are bypassed when parenteral medications are introduced either intramuscularly (I.M.) or intravenously (I.V.) directly into the body. The processing of raw materials into finished dosage forms must comply at all times with cGMPs and must be able to support process validation. Mechanical design should include HVAC Classifications considered essential to attain global regulatory acceptance. For classifications, see the ISPE® Guide for Sterile Manufacturing Facilities. The desire for increased levels of sterility assurance has led the FDA to promote the use of terminal sterilization for aseptically filled products. The FDA has stated that terminal sterilization processing is the method of choice unless the manufacturer can show that it is detrimental to the product. Terminal sterilization may be accomplished using autoclaves that apply overpressure to balance the pressures that are developed across the inside and outside of the containers. Because of product sensitivities, biologics, and blood products are not appropriate applications for terminal sterilization.

Filtration is defined as a mechanical or physical operation which is used for the separation of solids from fluids (liquids or gases) by interposing a medium through which only the fluid can pass. Oversize solids in the fluid are retained, but the separation is not complete; solids will be contaminated with some fluid and filtrate will contain fine particles (depending on the pore size and filter thickness).

Final Bulk Product is defined as the final drug product after chemical or biological processing and purification, ready for concentration, drying, and filling into containers prior to dispensing and final filling.

Finished Product is defined as the medicinal product that has undergone all stages of production, including packaging in its final container. The specifications for release of the finished product must comply with the FDA regulations. The specifications of the finished product at manufacture may be different from those of the medicinal product at expiry.

Flow Cytometry is defined as the analysis of biological material by detection of light-absorbing or fluorescing properties of cells or subcellular fractions (i.e., chromosomes) passing in a narrow stream through a laser beam. An absorbance or fluorescence profile of the sample is produced. Automated sorting devices, used to fractionate samples, sort successive droplets of th