EMA: Concept paper on the need for revision of the note for guidance on the evaluation of the pharmacokinetics of medicinal products in patients with impaired renal function

The note for guidance on the evaluation of the pharmacokinetics of medicinal products in patients with impaired renal function (CHMP/EWP/225/02) provides recommendations on when to conduct pharmacokinetic studies in patients with reduced renal function, design and evaluation of such studies and how to develop dosage recommendations in patients with renal impairment. This concept paper discusses the need to revise some sections of the guideline.