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- W59518997 abstract "Therapeutic products go through two distinct stages during their progress toward commercialization: drug discovery and drug development. The drug discovery stage focuses on the identification of an optimized drug candidate which then, in drug development, is put into human testing to determine its value as a clinical therapeutic. There is no standardized method for drug discovery although modern drug discovery operations have developed a series of consensus steps that can be used as a general guide for the drug discovery process. These include: target selection and validation, assay development, screening, chemical analog synthesis for lead optimization, and animal model testing. Clinical drug development, overseen by regulatory authorities (FDA in the United States), includes clinical transition (chemical, pharmacological, and toxicological studies designed to provide evidence for human safely), safety trials in healthy volunteers (Phase 1), safety and preliminary efficacy trials in patients (Phase 2), and clinical efficacy trials in patients (Phase 3)." @default.
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- W59518997 date "2014-01-01" @default.
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- W59518997 title "Therapeutic Drug Development and Human Clinical Trials" @default.
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- W59518997 doi "https://doi.org/10.1016/b978-0-12-404730-3.00023-3" @default.
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