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The backdrop against which each new drug is first introduced to man includes a voluminous preclinical dossier containing information of jarring contrasts. Distinct and precise is the information on chemistry and structure of the drug—an obvious tribute to the wondrous achievements of current chemistry. Little else in this dossier, however, is exact or can be interpreted so unerringly as can the drug chemistry. Oh, it is clear that this new drug has been administered "safely" to each of several animal species and that the desired pharmacologic effects are documented in one or more animal test models. And the statisticians unequivocally
The Principles and Practice of Clinical Trials.. Ann Intern Med. ;74:1020. doi: 10.7326/0003-4819-74-6-1020_1
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Published: Ann Intern Med. 1971;74(6):1020.
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