Antimicrobial Dose Selection under the Animal Rule

The Food and Drug Administration's (FDA's) "Animal Rule" provides a unique regulatory pathway for drugs and biologics intended to treat serious or life-threatening conditions caused by exposure to lethal or permanently disabling chemical, biological, radiological, or nuclear agen...

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Bibliographic Details
Published inClinical pharmacology and therapeutics Vol. 109; no. 4; p. 971
Main Authors Wu, Kunyi, Choi, Su-Young, Bergman, Kimberly, Seo, Shirley
Format Journal Article
LanguageEnglish
Published United States 01.04.2021
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Summary:The Food and Drug Administration's (FDA's) "Animal Rule" provides a unique regulatory pathway for drugs and biologics intended to treat serious or life-threatening conditions caused by exposure to lethal or permanently disabling chemical, biological, radiological, or nuclear agents when human efficacy studies are not ethical and field trials are not feasible. Human dose selection under the Animal Rule is based on integrating the totality of clinical pharmacology evidence collected in in vitro, animal, and human studies. This review discusses the necessary pharmacokinetic and pharmacodynamic information and methods for determining the effective human dose of antimicrobials under the Animal Rule and presents case studies illustrating the utility of a totality of evidence approach for different methods.
ISSN:1532-6535
DOI:10.1002/cpt.2201