Obesity and Drug Dosing: Clinical Pharmacology Considerations; Request for Comments

Resumen

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.