Docket Number:
FDA-2010-D-0133
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

This guidance is intended to assist sponsors planning to conduct studies to assess the influence of renal impairment on the pharmacokinetics of an investigational drug. It provides recommendations on when studies should be conducted to assess the influence of renal impairment on the pharmacokinetics of an investigational drug, the design of such studies, and how such studies should be carried out.

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All written comments should be identified with this document's docket number: FDA-2010-D-0133 .