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November 1969

Proving New Drugs: A Guide to Clinical Trials.

Arch Intern Med. 1969;124(5):646-647. doi:10.1001/archinte.1969.00300210128040

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Taber has written an interesting book which touches on the problems of experimental design for research and development of pharmaceutical products. He divides the material into two parts: (1) "The Participants," and (2) "The Clinical Study." The first portion reviews the qualifications, responsibility, and activities of the principals, namely, monitor, statistician, investigator, and patient. The second portion discusses the planning and design of the research, the protocol for the study, determinants for choosing investigators, filing of the investigational new drug application (IND), handling of experimental data, and filing of the actual new drug application (NDA).

Taber has drawn on his wide experience in fashioning the step-by-step handling of clinical trials from the preclinical testing phase through the filing of the NDA. A number of valuable suggestions are made which can be helpful to prospective clinical investigators and other scientists on the drug development team. Taber has used good judgment in

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