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Shows how the appropriate use of clinical materials can increase efficiency in bringing new products to the marketplace-offering authoritative assessments of the scientific and legal issues involved in the successful completion of clinical trials for marketing approval by regulatory agencies.

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9780824798529

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This practical guideoffer[s] authoritative evaluations of the scientific & legal issues involved in the successful completion of clin trials for marketing approval by regulatory agencies. -Unlisted Drugs very comprehensive on the subject and does give a lot of how-to information. very well written and very much geared towards the US market and Food and Drug Administration requirements. covers the process of clinical development and the involvement of the clinical trials materials manager at all stages. There is an excellent chapter on contract manufacturing. -European Journal of Parenteral Sciences describes both the science and the management of product development and furnishes effective approaches for preclinical drug discovery. -BOOKNews on the Internet

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