Terminologies (L-P) Flashcards
Printed materials that accompany a prescription drug when shipped in interstate commerce.
Labelling
An agent with a strong affinity to a metal ion.
Ligand
A batch, or a specific identified portion of a batch having uniform character and quality within specified limits. For an API produced by continuous process, it is a specific identified
amount produced in a unit of time or quantity in a manner that ensures its having uniform character and quality within specified limits.
Lot
Any distinctive combination of letters, numbers, or symbols, or any combination of them, from which the complete history of the manufacture, processing, packing, holding, and distribution of a batch or lot of an API or other material can be determined.
Lot number (control number, or batch number)
All operations used to manufacture an API to include packaging and labeling operations, testing, and quality control of an API.
Manufacture, processing, packing, or holding
The residual saturated liquid that remains after crystallization. A mother liquor may contain unrecovered or unreacted starting materials, intermediates, the API and/or impurities.
Mother liquor
A formal application to the FDA for approval to market a new drug product. When the investigational phase of a drug is completed, the manufacturer gathers together the results of all studies and submits them to the FDA in a New Drug Application. This application is reviewed in detail by a team of reviewers. The purpose of the NDA is to determine whether the drug meets the statutory standards for safety, effectiveness, labeling and manufacturing
New Drug Application (NDA)
The designated therapeutic moiety (API) in a dosage form that has not been approved for marketing in the United States (also referred to as a new chemical entity or new drug substance). It may be a complex, simple ester, or salt of a previously approved API.
New molecular entity
Any filter which, after any appropriate treatment such as washing or flushing, will not release fibers into the component or drug product that is being filtered. All filters composed of asbestos are deemed to be fiber-releasing filters.
Non-fiber-releasing filter
The documented verification that the identified system or subsystem performs as intended throughout all operating ranges of pressure and temperature.
Operational Qualification (OQ)
Any drug that can be bought without a prescription. Distribution of nonprescription drugs is unrestricted, and may be sold, for example, in grocery stores and pharmacies.
Over-the-counter drug (also OTC drug or nonprescription drug)
A process in which a diluted nitric acid solution is used to remove discoloration from weld areas as well as dissolve and flush out all iron particulates and residue. These deposits may be the result of being improperly cleaned and stored at the mill, the fab shop or the site. In the case of piping systems the process involves circulating the heated nitric acid solution for a period of time followed by a thorough flushing with potable or purified water. A test is then done to determine if free iron can be detected. When the test determines that the system is clear of any contaminants potable or purified water is flushed through the system until the pH and conductivity/resistivity of the effluent water samples are the same as that of the influent.
Passivation
The ratio of the actual yield (at any appropriate phase of the manufacture, processing, or packing of a particular drug product) to the theoretical yield (at the same phase), stated as a percentage.
Percentage of theoretical yield
Provides documented evidence that the integrated system
or process is capable of consistently producing the intended product in a high quality and safe manner
Performance Qualification (PQ)
Referring to pharmacy or medical drugs; any therapeutic product used in medicine. A pharmaceutical is a drug derived from organic or inorganic chemicals and used to treat a wide range of medical conditions.
Pharmaceutical
Formerly known as PMA, this is a nonprofit scientific and professional organization of more than 100 firms that discover, develop and produce prescription drugs and biological products in the United States. The Association’s members produce most of the prescription drugs used in the
United States and about half of the free world’s supply of prescription drugs. pharmacodynamics: The study of drug action primarily in terms of drug structure, site of action, and the biochemical and physiological consequences of the action.
Pharmaceutical Research and Manufacturers of America
(PhRMA)
Studies focusing on the total impact of the product or services on the health system. Pharmacoeconomics relies upon several economic methodologies, including cost-benefit, cost-effectiveness and cost-utility analysis.
Pharmacoeconomics
The study of how the body handles a drug, with particular emphasis on the time required for absorption, duration of action, distribution through the body and method of excretion.
Pharmacokinetics
The science that deals with the study of drugs in all aspects, including drugs’ mechanisms of action
Pharmacology
Small studies involving healthy volunteers to assess drug tolerability (safety), metabolism, structure-activity relationships, and mechanism of action in humans.
Phase I clinical trials
Tests designed to determine, under controlled conditions, whether or not a drug has therapeutic benefit (efficacy) with individuals having the target disease (patients) and document eventual short term side effects (adverse reactions) and risks associated with the drug.
Phase II clinical trials
Larger studies to gain confirmatory efficacy and safety data in a broad base of patients. The compound is given to patients according to a protocol that reflects the way the compound is
expected to used when it is on the market. These expanded studies generally include hundreds of site locations and involve thousands of patients.
Phase III clinical trials
Trials that come after the new drug application is filed, but before the product is approved for marketing. The goal of these studies is to provide additional data for marketing support and the ultimate product launch, including conducting country-specific studies to support local needs.
Phase IIIb clinical trials
Tests conducted after marketing to obtain additional data regarding product safety and efficacy over the life of a drug. The pharmaceutical is on the market and generating revenue during
this period.
Phase IV human testing or post-marketing surveillance
