The US Food and Drug Administration (FDA) has updated its draft guidance for the design and analysis of trials to assess how impaired renal function impacts the pharmacokinetics and pharmacodynamics of investigational drugs.
The guidance, issued on 03 September 2020, provides an update to a previous draft issued in March 2010. Specifically, the new document offers updated advice on when a standalone pharmacokinetic study is necessary, the appropriate study design, considerations for patients undergoing dialysis, and how to use pharmacokinetic data from Phase 2 and 3 studies.
The changes to the draft guidance arose mainly from a May 2019 meeting of the FDA’s Pharmaceutical Science and Clinical Pharmacology Advisory Committee. The committee considered the evaluation of patients with renal impairment during drug development and its impact on dosing and labeling.
There are a variety of ways that drug sponsors can assess the impact of impaired renal function on a drug’s pharmacokinetics, ranging from standalone studies, to modeling and simulation strategies, to alternative enrollment designs…