This glossary is a valuable resource designed to empower you with the knowledge needed to navigate the intricacies of medical and healthcare terminology. Each definition is meticulously curated from authoritative medical literature and trusted sources, ensuring that you receive accurate and comprehensible information. Whether you are a healthcare professional, a student, or an individual who is under medical treatment, our glossary is here to provide definitions of the language of medicine.
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.
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 function of the body.
Excipients are inactive substances that are added to pharmaceutical formulations alongside the active ingredient(s) to enhance the stability, bioavailability, and overall performance of the drug. These substances are not intended to have a therapeutic effect but serve various functions in the formulation process. The selection of excipients depends on the type of drug, its intended use, and the desired characteristics of the final dosage form. Excipients play a crucial role in ensuring the safety, efficacy, and overall quality of pharmaceutical products
In the context of medicines, the term "composition" refers to the formulation or combination of various components that make up a pharmaceutical product. The composition of a medicine includes both the active ingredient(s) and inactive ingredients, known as excipients. The specific combination and concentration of active and inactive ingredients in a medicine are crucial for ensuring the drug’s safety, efficacy, and stability.
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.
A Vaccine is a biological preparation that improves immunity to a particular disease. A vaccine typically contains an agent that resembles a disease-causing microorganism, and is often made from weakened or killed forms of the microbe or its toxins. The agent stimulates the body's immune system to recognize the agent as foreign, destroy it, and 'recognize' it, so that the immune system can more easily recognize and destroy any of these microorganisms that it later encounters. Vaccines can be prophylactic (e.g. to prevent or ameliorate the effects of a future infection by any natural or 'wild' pathogen), or therapeutic (e.g. vaccines against cancer).
Immunology is a broad branch of biomedical science that covers the study of all aspects of the immune system in all organisms. It deals with the physiological functioning of the immune system in states of both health and disease; malfunctions of the immune system in immunological disorders (autoimmune diseases, hypersensitivities, immune deficiency, transplant rejection); the physical, chemical and physiological characteristics of the components of the immune system in vitro, in situ, and in vivo.
A Hormone is defined as a chemical released by a cell or a gland in one part of the body that sends out messages that affect cells in other parts of the organism. Only a small amount of hormone is required to alter cell metabolism. In essence, it is a chemical messenger that transports a signal from one cell to another. All multicellular organisms produce hormones; plant hormones are also called phytohormones. Cells respond to a hormone when they express a specific receptor for that hormone. The hormone binds to the receptor protein, resulting in the activation of a signal transduction mechanism that ultimately leads to cell type-specific responses.
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 Vascular Disease is a form of cardiovascular disease primarily affecting the blood vessels. Vascular disease is a pathological state of large and medium sized muscular arteries and is triggered by endothelial cell dysfunction. The process causes thickening of the vessel wall, forming a plaque consisting of proliferating smooth muscle cells, macrophages and various types of lymphocytes. This plaque result in obstructed blood flow leading to diminished amounts of oxygen and nutrients that reaches the target organ. In the final stages, the plaque may also rupture causing the formation of clots, and as a result strokes.
Metabolic Diseases, also referred to as inborn errors of metabolism, congenital metabolic diseases or inherited metabolic diseases comprise a large class of genetic diseases involving disorders of metabolism. The majority are due to defects of single genes that code for enzymes that facilitate conversion of various substances (substrates) into others (products). In most of the disorders, problems arise due to accumulation of substances which are toxic or interfere with normal function, or to the effects of reduced ability to synthesize essential compounds.
Research can be defined as the search for knowledge or as any systematic investigation to establish facts. The primary purpose for applied research (as opposed to basic research) is discovering, interpreting, and the development of methods and systems for the advancement of human knowledge on a wide variety of scientific matters.
Insulin is a hormone that is central to regulating fat and steroids metabolism in the body. Insulin causes cells in the liver, muscle, and fat tissue to take up glucose from the blood, storing it as glycogen in the liver and muscle. Insulin is a peptide hormone composed of 51 amino acids and has a molecular weight of 5808 Da. It is produced in the islets of Langerhans in the pancreas. Insulin’s structure varies slightly between species of animal. Insulin from animal sources differs somewhat in "strength" (in carbohydrate metabolism control effects) in humans because of those variations.
The molecular weight is the sum of all atomic weights of the constituent atoms in a compound, measured in gr/mol. In the absence of explicit isotope labeling, averaged natural abundance (which may, for example in case of Li and U compounds, not be identical to purchasable material) is assumed. If an atom bears an explicit isotope label, 100% isotopic purity is assumed at this location, even for short-lived radioactive isotopes where this is often physically unrealistic.
Therapeutic indications of a drug refer to the specific medical conditions or diseases for which the drug is intended to be used to provide a therapeutic benefit. These indications are determined through clinical trials and research. Healthcare providers rely on the therapeutic indications to make informed decisions about prescribing medications, ensuring that the right drug is used for the right patient and medical condition.
A response to a medicine which is noxious and unintended and which occurs at doses normally used in man for the prophylaxis, diagnosis or therapy of disease or for the restoration, correction or modification of physiological function.
Warnings and precautions in drugs refer to specific information provided by pharmaceutical manufacturers to healthcare professionals and patients regarding potential risks, adverse effects, or special considerations associated with the use of a particular medication. This information is crucial for ensuring the safe and effective use of the drug and helps healthcare providers and individuals make informed decisions about its administration.
The method of administration in drug use refers to the specific way or route by which a drug is introduced into the body for therapeutic purposes. Different drugs are formulated and designed to be administered through various routes, each with its advantages, disadvantages, and considerations. The choice of the method of administration depends on various factors, including the drug’s properties, the patient’s condition, the desired therapeutic effect, and considerations of patient preference and compliance.
Contraindications in medicines refer to specific situations, conditions, or factors that make it inadvisable or potentially dangerous to administer a particular drug or treatment to an individual. These contraindications are based on factors such as the individual’s medical history, current health status, and the potential interactions between the drug and the person’s physiological condition.
Undesirable effects in medicines refer to the unintended or adverse effects that can occur when taking a medication. These effects are also commonly known as side effects. While the primary purpose of a medication is to provide therapeutic benefits, undesirable effects may occur as a result of the drug’s action on the body or its interaction with various physiological systems.
Medicine overdose occurs when an individual takes a higher amount of a medication than the prescribed or recommended dose, leading to potentially harmful or toxic effects. Overdosing on a medicine can result from intentional misuse, accidental ingestion of too much medication, or a failure to recognize the correct dosage. The severity of the overdose and its symptoms depend on the specific medication involved, the amount ingested, and individual factors such as age, weight, and overall health. Different medications have different toxic levels, and the consequences of an overdose can vary widely. In severe cases, a medicine overdose can be life-threatening and may require emergency medical attention.
The shelf life of a drug refers to the period during which a pharmaceutical product, when stored under appropriate conditions, is expected to remain stable, retain its intended potency, and meet the specifications outlined by regulatory authorities. It is the time frame during which the drug is considered safe and effective for use.
The study of the biochemical and physiological effects of drugs and the mechanisms of their actions, including the correlation of their actions and effects with their chemical structures.
The study of the movement of drugs in the body, including the processes of absorption, distribution, and localization in tissues.
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 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.
Clinical efficacy refers to the extent to which a medical intervention, such as a drug or a medical procedure, achieves its intended therapeutic effect or produces a beneficial outcome in a clinical setting. It is a measure of the treatment’s ability to bring about the desired result, typically in terms of improvements in health, relief of symptoms, or positive impact on patient outcomes.
Preclinical safety data refer to the information obtained from laboratory and animal studies conducted before a new drug or medical intervention is tested in humans (clinical trials). These studies are a crucial part of the drug development process and aim to assess the safety, pharmacokinetics, and potential efficacy of the investigational product. The preclinical phase provides essential insights into how the drug behaves in biological systems and helps identify potential risks and adverse effects.
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 pharmacotherapeutic group refers to a group of medications that are classified together based on their shared pharmacological properties, therapeutic uses, and mode of action. Drugs within the same pharmacotherapeutic group typically target similar biological pathways or have similar effects on the body, making them useful for treating specific medical conditions.
Genomics is a discipline in genetics concerning the study of the genomes of organisms. The field includes intensive efforts to determine the entire DNA sequence of organisms and fine-scale genetic mapping efforts. The field also includes studies of intragenomic phenomena such as heterosis, epistasis, pleiotropy and other interactions between loci and alleles within the genome.
In-vitro (Latin: within the glass) is a procedure performed not in a living organism but in a controlled environment, such as in a test tube or Petri dish. Many experiments in cellular biology are conducted outside of organisms or cells; because the test conditions may not correspond to the conditions inside of the organism, this may lead to results that do not correspond to the situation that arises in a living organism.
In-vivo (Latin for "within the living") is experimentation using a whole, living organism as opposed to a partial or dead organism, or an in vitro controlled environment. Animal testing and clinical trials are two forms of in vivo research. In vivo testing is often employed over in vitro because it is better suited for observing the overall effects of an experiment on a living subject.
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.
Toxicology is a branch of biology and medicine concerned with the study of the adverse effects of chemicals on living organisms. It is the study of symptoms, mechanisms, treatments and detection of poisoning, especially the poisoning of people. There are various specialized sub disciplines within the field of toxicology that concern diverse chemical and biological aspects of this area. For example, toxicogenomics involves applying molecular profiling approaches to the study of toxicology. Other areas include Aquatic toxicology, Chemical toxicology, Ecotoxicology, Environmental toxicology, Forensic toxicology, and Medical toxicology.
Paediatric refers to the branch of medicine that deals with the medical care of infants, children, and adolescents. The age limit of such patients ranges from birth to 18. In countries where the age of majority is 18, this age limit may be from birth to age 17 (such as in Canada). A medical practitioner who specializes in this area is known as a pediatrician.
Beta-adrenergic blocking agents, or beta-blockers for short, reduce the oxygen needs of the heart by reducing heartbeat rate.
The term Medical Device refers to any health care product that does not achieve its principal intended purposes by chemical action in or on the body or by being metabolized. The term "devices" also includes components, parts, or accessories of medical devices, diagnostic aids such as reagents, antibiotic sensitivity disks, and test kits for in vitro diagnosis of diseases and other conditions. There are three classes of medical devices: Class I (General Controls which include registration of manufacturers, recordkeeping and labeling requirements, compliance with GMPs), Class II (Special Controls which includes performance standards, post market surveillance, and patient registries) and Class III (Premarket Approval which includes implanted and life supporting or life sustaining devices).
Pharmaceutical form, also known as dosage form, refers to the specific physical form in which a pharmaceutical product is presented for administration. It describes the way in which a drug is formulated and the physical state or appearance of the product. The pharmaceutical form is an important aspect of drug development, as it determines how the drug is delivered and administered to the patient. Common pharmaceutical forms include Tablets, Capsules, Oral Solutions and Syrups, Injections, Topical Creams and Ointments, Inhalers, Suppositories, Patches and Powders for reconstitution.
The nature of the container of a drug refers to the physical characteristics, composition, and design of the packaging used to contain and protect the pharmaceutical product. The choice of container is crucial for maintaining the stability, safety, and efficacy of the drug throughout its shelf life. The nature of the container encompasses various aspects, including materials, closure systems, and design features.
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.
Sterile Fluid-Path Packaging is defined as the system of protective port covers and/or packaging designed to be used to ensure sterility of the portion of the medical device intended for contact with fluids. An example of sterile fluid-path packaging would be the interior of the tubing for administration of an intravenous fluid.
A drug marketed under a brand name. Typically refers to products approved under an NDA or BLA/aBLA, though products approved under an ANDA may also be marketed with a brand name.
Similar to a wholesaler, but generally does not manage indirect contracts and chargebacks, or run source programs.
The marketing authorization holder (MAH) of a medicine is the entity or company that has been granted the legal right to market the medication. The MAH is responsible for obtaining regulatory approval from health authorities, ensuring compliance with regulatory requirements, and overseeing the commercialization of the drug.
Authorization numbers on drug packages typically refer to specific identification numbers or codes issued by regulatory authorities to authorize the marketing or distribution of a pharmaceutical product. These numbers are part of the drug's regulatory documentation and packaging to ensure traceability, regulatory compliance, and pharmacovigilance. The specific terminology and format of authorization numbers may vary between countries and regulatory agencies.
A numeric code that uniquely identifies drug products. The code includes three segments that identify the labeler, the product, and the packaging.
In the European Union, medicinal products receive a marketing authorization (MA) number, which is also known as the European Medicines Agency (EMA) number. This number is typically displayed on the product packaging and serves as a unique identifier for authorized medicines within the EU.
In Canada, pharmaceutical products are assigned a Drug Identification Number (DIN). The DIN is an eight-digit number that appears on the product label and packaging, indicating that the drug has been authorized for sale by Health Canada.
