Following FDA approval and marketing, drug companies may conduct further studies on their products. These post-approval studies have several objectives, including comparing the drug with other drugs already in the market, monitoring the drug's long-term effectiveness, and determining additional potential uses for the drug.
Glossary
Phase IV
02.27.12
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Hot Melt Extrusion (HME)
Type of extrusion that uses compaction and conversion of blends from a powder or a granular mix into a product of uniform shape. HME has several potential advantages over traditional processing techniques such as spray drying or roll spinning, includ…03.26.13
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Plant-Made Pharmaceutical (PMP)
The process of genetically engineering plants so that they can produce certain types of therapeutically important proteins and associate molecules, such as peptides and secondary metabolites. The proteins and molecules can then be harvested and used…03.25.13
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Validation
Method Qualification
Studies carried out to analyze the quality of an analytical method and to check the "readiness" of a method for validation. The parameters tested in these studies may include specificity, matrix effects, linearity, robustness, etc. Results…03.25.13
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SafeBridge Certification
An occupational health and safety assessment of a company's ability to safely handle and manufacture potent compounds. The program focuses on four primary areas: (1) management, (2) hazard identification and evaluation, (3) hazard controls, and (…03.25.13
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Guidance Document
Documents that represent FDA's current thinking on a topic. In the agency's words, "They do not create or confer any rights for or on any person and do not operate to bind FDA or the public. You can use an alternative approach if the app…03.25.13
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Institutional Review Board (IRB)
A committee formally designated to approve, monitor, and review biomedical research involving humans. An IRB has the authority to approve, require modifications in (to secure approval), or disapprove research. This group review serves a role in the p…03.25.13
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Supercritical Fluid Chromatography (SFC)
A form of normal phase chromatography that is used for the analysis and purification of low to moderate molecular weight, thermally labile molecules. It can also be used for the separation of chiral compounds.…03.25.13
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APIs
Animal-Derived Ingredient (ADI)
Per FDA, "A substance of animal origin used to manufacture a drug product. They are primarily derived from by-products of food production and include extractions from certain animal material, and include milked animal fluids (e.g., venoms) and m…03.25.13
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No Observed Adverse Effect Level (NOAEL)
A dose in toxicology studies that produces no adverse effects.…03.25.13
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Inspections
Generic Drug User Fee Amendments (GDUFA)
A user fee model for generic drugs, passed by Congress and insituted by FDA in 2012, "to speed access to safe and effective generic drugs to the public and reduce costs to industry," according to FDA. GDUFA requires industry to pay user fee…03.25.13
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Capsules
Microcapsule
Microcapsules are small particles that contain an active ingredient or core material and are surrounded by a coating or shell. They often have a diameter between 3 and 800 microns. See also Microencapsulation…03.25.13
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Wurster Process
A technique, invented by Dale Wurster at the University of Wisconsin, for applying a coating onto particulate solids (typically 20 to 2,000 microns) in which the particles are moved in a circulating fashion using fluidizing air streams with different…03.25.13
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APIs
Photooxidation
The process by which light catalyzes the oxidation of a chemical compound. Some APIs may need to be protected from light because they are subject to photooxidation.…03.19.13
