Glossary


  • 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

  • Independent Data Monitoring Committee (IDMC)

    An independent committee of clinicians and statisticians whose task is to review the status of a clinical trial and make recommendations to the clinical research group concerning the trial’s continuation, modification and/or publication.…
    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

  • SFC

    See Supercritical Fluid Chromatography.…
    03.25.13

  • Polyclonal Antibody (PAb)

    Antibodies that have been obtained by immunization of an animal. They are the products of different clones of antibody-producing cells, as opposed to Monoclonal Antibody, which consists of a single immunoglobulin derived from its parent lymphocytes.…
    03.25.13

  • PAb

    See Polyclonal Antibody.…
    03.25.13

  • Personalized medicine

    A medical model that proposes the customization of healthcare, tailoring decisions, practices, and/or products to the individual patient by use of genetic or other information.…
    03.25.13

  • Nuclear Magnetic Resonance (NMR)

    A spectroscopic technique used by scientists to characterize chemical structures and molecular dynamics. Can provide detailed information on the topology, dynamics and three-dimensional structure of molecules in solution and the solid state.…
    03.25.13

  • Differential Scanning Calorimetry (DSC)

    A thermoanalytical technique in which the difference in the amount of heat required to increase the temperature of a sample and reference is measured as a function of temperature. Useful in characterizing drug compounds in order to define processing…
    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

  • ADI

    See Animal-Derived Ingredient.…
    03.25.13

  • MBP

    See Microprecipitated Bulk Powder.…
    03.25.13

  • Microprecipitated Bulk Powder (MBP)

    A "powder" consisting of a drug in an amorphous state stabilized by a carrier (e.g., polymer). The net result is that a significant increase in bioavailability of the drug is achieved (over the drug, per se) when the powder is incorporated…
    03.25.13

  • Acceptable Daily Exposure (ADE)

    A dose that is unlikely to cause an adverse effect if an individual is exposed by any route at or below this dose every day for a lifetime.  Reference ISPE September 2010 Risk-MaPP Baseline® Guide.…
    03.25.13

  • ADE

    See Acceptable Daily Exposure.…
    03.25.13

  • Permitted Daily Exposure (PDE)

    A substance specific dose that is unlikely to cause an adverse effect if an individual is exposed at or below this dose every day for a lifetime. Reference EMA December 2012 Guideline on setting health based exposure limits for use in risk identifica…
    03.25.13

  • PDE

    See Permitted Daily Exposure.…
    03.25.13

  • No Observed Adverse Effect Level (NOAEL)

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

  • NOAEL

    See No Observed Adverse Effect Level.…
    03.25.13