The animal rule: The role of clinical pharmacology in determining an effective dose in humans.

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. Published 2015. This article is a U.S. Government work and is in the public domain in the USA.