Episode 12 · October 23, 2023 · 14 min

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

Speed

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

Related episodes

Ep 14Nov 27, 202320 min

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…

Ep 8Aug 28, 202331 min

QT Prolongation Guidance ICH E14 (Ep. 8)

This episode is a discussion of the FDA and ICH guidance E14 titled “Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs”. I start with…

Ep 11Oct 9, 202331 min

Model diagnostics and selection (Ep. 11)

This episode is a discussion on model evaluation and selection. I discussed diagnostic plots using predictions and residuals. I covered approaches for model selection and factors to consider. The…

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

Related episodes

Clinical Drug Interaction Studies (Ep. 14)

QT Prolongation Guidance ICH E14 (Ep. 8)

Model diagnostics and selection (Ep. 11)

Never miss an episode