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Clinical Testing of New Drugs

Vincent J. Gagliardi, MD
JAMA. 1965;193(5):407-408. doi:10.1001/jama.1965.03090050083048.
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The book reflects growing concern with the need for better testing of new drugs. The need is felt in two main areas. In preclinical testing broader and more predictive animal toxicity tests should be used, including those designed to show teratogenicity. In clinical investigations there should be better study-design and attention to clinical pharmacology. The goals are, to insure that drugs do what they are supposed to do and that their limitations are fully explored.

Participating in drug evaluation in general, and contributing to this book in particular, are personnel associated with research, the pharmaceutical industry, clinical investigators, statisticians, and regulatory agencies. Twenty-one contributors have written 27 chapters which tell what happens to a drug from inception to reception. Each observes his field, comments on the limitations (which are often the limitations of science itself), and indicates what improvements can be made. There is some repetition and overlap, but in


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