FDA Issues Advice on Pharmacokinetics in Patients with Impaired Renal Function
The FDA released a draft guidance last week advising drug sponsors on pharmacokinetic studies for patients with impaired renal function.
The guidance suggests dedicated pharmacokinetic studies when a drug is likely to be used in such patients and when impaired renal function can alter a drug’s pharmacokinetics or its active metabolites.
Dedicated studies are not recommended for drugs that are gaseous or volatile drugs and those have active metabolites that are eliminated through the lungs, the agency said. Studies are also not recommended for drugs intended for single-dose administration and if the drugs are locally acting with limited systemic absorption.
The guidance includes recommendations for characterizing a drug’s pharmacokinetics in patients undergoing dialytic therapies, and how to use data from phase 2 and 3 trials to inform dosing recommendations for patients with impaired renal function. It also addresses how to report the results of studies that assess the impact of impaired renal function on drugs.
Read the draft guidance here: https://bit.ly/3337PeM.