Guidance for Industry. Pharmacokinetics in Patients with Impaired Renal Function211 Study Design, Data Analysis, and Impact on Dosing and Labeling

摘要

This guidance is intended for sponsors who, during the investigational phase of211u001edrug development, plan to conduct studies to assess the influence of renal 211u001eimpairment on the pharmacokinetics of an investigational drug. This guidance 211u001emakes recommendations regarding: when studies of PK in patients with impaired 211u001erenal function should be performed--and conversely, when they may be unecessary; 211u001ethe design and conduct of PK studies in patients with impaired renal function; 211u001ethe design and conduct of PK studies in end-stage renal disease (ESRD) patients 211u001etreated with dialysis (hemodialysis or peritoneal dialysis); the analysis and 211u001ereporting of the results of such studies; and representation of these results in 211u001eapproved product labeling.