Clinical Drug Interaction Studies (Ep. 14)

In today’s episode I covered the different types of drug interactions, followed by features of clinical drug evaluation studies recommended in the guidance. Then I will review recommendations for both stand-alone clinical drug interaction studies, as well as nested drug interaction studies. I’ll finish with recommended approaches for interpreting drug interaction study results and expressing that information in drug labeling.

Links discussed in the show:

• Prevalence and factors associated with polypharmacy: a systematic review and meta-analysis by Delara et al.
• FDA guidance on clinical drug interactions
• FDA guidance on in vitro drug interactions
• FDA guidance on therapeutic protein drug interactions
• EMA guideline on drug interactions
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