In today’s episode I discuss the evaluation of pharmacokinetics in patients with impaired renal function. I include information from both the US FDA and EMA guidance documents linked below. I discuss the determination of when a dedicated renal impairment study is needed, characteristics of the study design and how to analyze and interpret the results.

Links discussed in the show:

• FDA guidance on PK in patients with impaired renal function

• EMA guidance on Evaluation of PK in patients with decreased renal function

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