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New Drugs: An Insider's Guide to the FDA's New Drug Approval Process for Scientists, Investors and Patients

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New Drugs: An Insider's Guide to the FDA's New Drug Approval Process for Scientists, Investors and Patients - Friedhoff MD, Lawrence T
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Drug development, the processes by which a chemical compound becomes a "drug" and is approved for sale by the FDA and European and Asian regulators, is not for the faint-of-heart or the shortsighted. Designing and monitoring studies, obtaining and analyzing scientific data, and reconciling clinical results against the ethical constraints and regulatory guidelines of government agencies, requires a complex interaction of in-house specialists and academic and commercial consultants worldwide. Scientific, technical, and ...

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New Drugs: An Insider's Guide to the FDA's New Drug Approval Process for Scientists, Investors and Patients 2009, Booksurge Publishing

ISBN-13: 9781419699610

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