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

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

    FromClinical Pharmacology Podcast with Nathan Teuscher

    Start listeningView podcast show

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

    FromClinical Pharmacology Podcast with Nathan Teuscher

    ratings:
    Length:
    14 minutes
    Released:
    Oct 23, 2023
    Format:
    Podcast episode

    Description

    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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    Copyright Teuscher Solutions LLC
    All Rights Reserved
    Released:
    Oct 23, 2023
    Format:
    Podcast episode

    Titles in the series (27)

    I discuss clinical pharmacology and pharmacometrics topics from the perspective of drug development scientists. I share my expertise and knowledge about designing and conducting clinical pharmacology studies and discuss how to analyze the data using the most effective approaches. I draw from my experience of over 20 years working in drug development organizations and consultancies.