Glossary

Combination Product

02.27.12

According to FDA: 1) A product comprised of two or more regulated components, i.e., drug/device, biologic/device, drug/biologic, or drug/device/biologic, that are physically, chemically, or otherwise combined or mixed and produced as a single entity; (2) Two or more separate products packaged together in a single package or as a unit and comprised of drug and device products, device and biological products, or biological and drug products; (3) A drug, device, or biological product packaged separately that according to its investigational plan or proposed labeling is intended for use only with an approved individually specified drug, device, or biological product where both are required to achieve the intended use, indication, or effect and where upon approval of the proposed product the labeling of the approved product would need to be changed, e.g., to reflect a change in intended use, dosage form, strength, route of administration, or significant change in dose; or (4) Any investigational drug, device, or biological product packaged separately that according to its proposed labeling is for use only with another individually specified investigational drug, device, or biological product where both are required to achieve the intended use, indication, or effect.
  • 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