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The animal rule: The role of clinical pharmacology in determining an effective dose in humans
Author(s) -
Bergman KL
Publication year - 2015
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1002/cpt.172
Subject(s) - clinical pharmacology , pharmacology , medicine , cornerstone , preclinical research , human studies , medical physics , art , visual arts
Development of drugs and biologics for which adequate and well‐controlled efficacy studies in humans cannot be ethically conducted or are not feasible poses significant challenges. For these agents, clinical pharmacology information is used to translate preclinical efficacy findings to humans and is a cornerstone that supports a human dose. This article focuses on the role of clinical pharmacology in determining the human dose for new drugs and biologics under the Animal Rule regulatory pathway.