Glossary

Generic Drug

02.27.12

A drug product sold under the provisions of Section 505(j) of the Federal Food, Drug and Cosmetic Act. The Abbreviated New Drug Application (ANDA) was enabled through the Drug Price Competition and Patent Term Restoration Act of 1984 (Hatch-Waxman). The ANDA must contain (1) information to show conditions of the proposed generic drug's labeling have been previously approved for the "reference listed drug" (RLD), (2) that the generic drug is pharmaceutically equivalent to the RLD (same active ingredient, route of administration, dosage form and strength), (3) that the generic drug is bioequivalent to the RLD, (4) the generic drug must have the same labeling as the RLD, and (5) the generic drug must be manufactured in compliance with cGMPs. Finally, with regard to patents, the sponsor of a generic drug application must certify to the FDA that (I) information on any patents were not filed by the NDA holder with FDA, (II) relevant patent(s) have expired, (III) relevant patent(s) will expire on some future date, or (IV) relevant patent(s) are invalid or would not be infringed by the manufacture of a generic version.
  • 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

  • HME

    See Hot Melt Extrusion.…
    03.26.13

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • No Observed Adverse Effect Level (NOAEL)

    A dose in toxicology studies that produces no adverse effects.…
    03.25.13

  • GDUFA

    See Generic Drug User Fee Amendments.…
    03.25.13

  • 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

  • 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

  • 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

  • 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

  • Capsules

    Single-Use System (SUS)

    Systems consisting of fluid path components to replace reusable stainless steel components. The most typical systems are made up of bag chambers, connectors, tubing and filter capsules. For more complex unit operations such as cross flow filtration o…
    03.19.13

  • Process Validation | Validation

    Continuous Process Verification

    An alternative approach to process validation in which manufacturing process performance is continuously monitored and evaluated.…
    03.19.13

  • ADC

    See Antibody-Drug Conjugates (ADCs)…
    03.19.13

  • Glass Delamination

    Glass delamination is the attack of the glass container by the drug product over its shelf-life, culminating in the appearance of thin flake-like particles in the drug product.…
    Gil Roth 03.12.13

  • Inhalation (by inhalation)

    A route of administration for aerosols characterized by dispersion of the API into the airways during inspiration.…
    03.29.12