Glossary

Pharmacology

02.27.12

The study of how drugs produce their effects. Pharmacology relies on knowledge of physiology, biochemistry, molecular biology, and other scientific disciplines.
  • Chemistry, Manufacturing, and Controls (CMC)

    The section on a BLA, IND, NDA or ANDA describing the composition, manufacture, and specifications of a drug product and its ingredients.…
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  • CMC

    See Chemistry, Manufacturing, and Controls.…
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  • Combinatorial Chemistry

    An approach to chemical synthesis that creates large numbers of organic compounds by putting chemical "building blocks" together in every possible combination. Combinatorial chemistry is used in the drug discovery process to create many lead compound…
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  • Computational Chemistry

    A discipline used for computer-aided drug design. Computer modeling attempts to predict the type of compounds (and the structures) most chemically suitable for binding to a drug target.…
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  • Extractable

    Soluble compounds derived from the test article, that migrate into an appropriate extracting solvent (or solvent mixture) under relatively aggressive incubation conditions. These conditions may include time, temperature, pH or other fluid chemistry p…
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  • Medicinal Chemistry

    A field of study that combines organic chemistry, analytical chemistry and other chemical disciplines for the discovery, optimization, and production of drugs. See Structure-Activity Relationship.…
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  • Liquid Chromatography/Mass Spectrometry (LC/MS)

    An analytical chemistry technique that combines the physical separation capabilities of liquid chromatography with the mass analysis capabilities of mass spectrometry. Tends to be used for the specific detection and potential identification of chemic…
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  • Process Analytical Technologies (PAT)

    According to the FDA, Process Analytical Technologies are systems for analysis and control of manufacturing processes based on timely measurements of critical quality parameters and performance attributes of raw and in-process materials and processes…
    02.27.12