Glossary

Combinatorial Chemistry

02.27.12

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 compounds that are screened against biological targets.
  • 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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  • Chemical Synthesis and Scale-Up

    A step in the drug discovery process in which a chemical process is expanded to produce adequate amounts of a potential drug compound for preclinical and clinical testing.…
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  • Process Development

    Chemical Process Development

    A step in the drug discovery process in which the chemical reactions necessary for the production of a drug are streamlined. Reactions are optimized, scaled up, and sometimes completely new routes are devised.…
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  • Absorption, Distribution, Metabolism and Excretion/Toxicology (ADME/T)

    The objective of ADME/T testing is to measure what happens to a compound in the human physiology. ADME/T tests are done during the preclinical stage of the drug discovery process and are a necessary part of any clinical trial, prior to filing an IND.…
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  • CMC

    See Chemistry, Manufacturing, and Controls.…
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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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  • Drug Discovery

    Identification of a biological, genetic or protein target linked to a particular disease, and subsequent lead identification of a potential drug that interacts with the target to help cure the disease or halt its progression.…
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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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  • Pharmacology

    The study of how drugs produce their effects. Pharmacology relies on knowledge of physiology, biochemistry, molecular biology, and other scientific disciplines.…
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  • Rational Drug Design

    Using the known three-dimensional structure of a molecule, usually a protein, to design a drug molecule that will bind to it. Usually viewed as an alternative to drug discovery through screening many molecules for biological activity.…
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  • Structure-Based Drug Design

    The process of drug discovery that uses a high-resolution picture of the drug target's structure. This can help develop a profile of the compound that would be the most suitable for that target.…
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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