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Should Obese Patients Be Included In Every Drug Development Program?

 
• By Brenda Sandburg

FDA officials question whether modeling tools can predict which drugs have different disposition in obese populations. They say physiologically-based pharmacokinetic data cannot be used as a surrogate for actual clinical trial data at this time.

Obese patient
Experts consider how obese patients should be included in drug development studies • Source: Shutterstock

Experts from the US Food and Drug Administration, academia and industry did not reach a consensus on whether obese patients should be considered a specific population in new drug development studies but they agreed that they should be included in trials and that modeling tools might provide insights on whether a compound’s dosing and disposition is different in obese patients.

Panelists discussed how to bridge drug efficacy and safety to obese patients at a virtual workshop convened by the FDA...

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