Obesity and Drug Dosing: Clinical Pharmacology Considerations; Request for Comments
The Food and Drug Administration (FDA) is establishing a public docket entitled "Obesity and Drug Dosing: Clinical Pharmacology Considerations." The Agency is soliciting input from interested persons on assessing the effect of obesity on drug pharmacokinetics and pharmacodynamics during drug (including biological product) development. These assessments could potentially inform whether obesity impacts the safety and effectiveness of the drug and dosing recommendations for obese patients.
Abstract as published in the Federal Register.
The complete document — every provision, the docket, and the comment instructions — is published in the Federal Register. SPEQ surfaces and indexes it for reference; the authoritative text lives on federalregister.gov.
View on federalregister.gov →Document details are published in the U.S. Federal Register; SPEQ surfaces them for reference and is not affiliated with or endorsed by the FDA or the Office of the Federal Register. The authoritative text is on federalregister.gov.