Glossary
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February 27, 2012
Carefully designed investigations of the effects of investigational new drugs, medical treatments, or devices on a group of patients. There are typically three phases of clinical trials prior to the filing of an NDA, sometimes followed by ongoing, po…
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February 27, 2012
The U.S. regulations that directly apply to biopharmaceutical development are contained in Title 21 parts 58 (Good Laboratory Practice for Nonclinical Laboratory Studies), 210 (Current Good Manufacturing Practice in Manufacturing, Processing, Packing…
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February 27, 2012
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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February 27, 2012
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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February 27, 2012
Confirmation by examining and providing objective evidence that computer system specifications conform to user needs and intended uses, and that all requirements can be consistently fulfilled.…
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February 27, 2012
A company that offers manufacturing services, with volume capabilities ranging from small amounts for preclinical R&D to larger volumes necessary for clinical trials purposes and commercialization.…
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February 27, 2012
A cellular process serving a specific purpose such as insulin regulation. These sequences of events can reveal the causes of problems such as tumor progression and help researchers target particular molecular processes to block with drugs.…
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February 27, 2012
A written agreement between a private company and a government agency to work together on a project. The collaborating partner agrees to provide funds, personnel, services, facilities, equipment or other resources needed to conduct a specific researc…
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