Dose Selection in a Pandemic: A Framework Informed by the FDA Animal Rule

Clin Transl Sci. 2021 Jan;14(1):5-7. doi: 10.1111/cts.12936. Epub 2020 Dec 16.

Authors

Kunyi Wu¹, Kimberly L Bergman¹

Affiliation

¹ Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research (CDER), US Food and Drug Administration (FDA), Silver Spring, Maryland, USA.

No abstract available

MeSH terms

Animals
Antiviral Agents / pharmacology*
Antiviral Agents / standards
Antiviral Agents / therapeutic use
COVID-19 / epidemiology
COVID-19 / virology
COVID-19 Drug Treatment*
Dose-Response Relationship, Drug
Drug Dosage Calculations*
Drug Evaluation, Preclinical / standards
Drug Evaluation, Preclinical / statistics & numerical data
Humans
Microbial Sensitivity Tests
Pandemics / prevention & control
Practice Guidelines as Topic
SARS-CoV-2 / drug effects
Uncertainty
United States / epidemiology
United States Food and Drug Administration / standards

Substances

Antiviral Agents