Authored by an IQVIA expert, this white paper explores considerations for including participants defined as obese based on their BMI in early-phase clinical trials. It delves into the pathophysiological changes associated with obesity that can influence a drug’s pharmacological profile, the regulatory landscape, and the use of tools such as in silico modeling and population pharmacokinetic analysis (PopPK).
Leverage a global network of Phase I clinical pharmacology units to build diversity in patient populations and access a range of geographic regions for early clinical development (ECD) programs.
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