– Institutional Review Boards and Investigational Use of Drugs



Research on Drug Use in Obese Patients (1013)

Source: Council on Therapeutics

To encourage drug product manufacturers to conduct pharmacokinetic and pharmacodynamic research in obese patients to facilitate safe and effective dosing of medications in this patient population, especially for medications most likely to be affected by obesity; further,

To encourage manufacturers to include in the Food and Drug Administration (FDA)-approved labeling detailed information on characteristics of individuals enrolled in drug dosing studies; further,

To advocate that the FDA develop guidance for the design and reporting of studies that support dosing recommendations in obese patients; further,

To advocate for increased enrollment of obese patients in preapproval clinical trials of new medications; further,

Only gold members can continue reading. Log In or Register to continue

Stay updated, free articles. Join our Telegram channel

Aug 27, 2016 | Posted by in GENERAL & FAMILY MEDICINE | Comments Off on – Institutional Review Boards and Investigational Use of Drugs

Full access? Get Clinical Tree

Get Clinical Tree app for offline access