PK in patients with impaired renal function (Ep. 12)

from Clinical Pharmacology Podcast with Nathan Teuscher · host Nathan Teuscher

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 • You can connect with me on LinkedIn and send me a message. • Send me a message • Sign up for my newsletter Copyright Teuscher Solutions LLC All Rights Reserved

Episode metadata supplied by the publisher feed · Published Oct 23, 2023

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PK in patients with impaired renal function (Ep. 12)

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This episode was published on October 23, 2023.

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