Should Obese Patients Be Included In Every Drug Development Program?
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.
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Both ideas also will require more FDA expertise, agency tells industry.
Merck must conduct studies to determine likely non-responders, assess occurrence of hypersensitivity or anaphylaxis, evaluate risk of cardiac arrhythmias, and study sugammadex's effects in morbidly obese patients.