Drug Regulator, FDA, Publishes Guidance on Pharmacokinetics in Patients with Impaired Renal Function, Study Design, Data Analysis, and Impact on Dosing and Labeling.
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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.
After entering the body, a drug is eliminated by excretion and/or by metabolism. Although elimination can occur through a variety of routes, most drugs are cleared by elimination of unchanged drug by the kidney and/or by metabolism in the liver and/or small intestine. If a drug is eliminated primarily through renal excretory mechanisms, impaired renal function usually alters the drug’s pharmacokinetics (PK) to an extent that the dosage regimen needs to be changed from that used in patients with normal renal function. The most obvious type ofchange arising from renal impairment is a decrease in renal excretion of a drug or its metabolites, but changes in renal metabolism can also occur. Renal impairment can adversely affect some pathways of hepatic/gut drug metabolism and has also been associated with other changes, such as changes in absorption, plasma protein binding, transport, and tissue distribution. These changes may be particularly prominent in patients with severely impaired renal function and have been observed even when the renal route is not the primary route of elimination of a drug. Thus, for most drugs that are likely to be administered to patients with renal impairment, including drugs that are not primarily excreted by the kidney, PK should be assessed in patients with renal impairment to provide appropriate dosing recommendations, with the exceptions described in section III.B.
This guidance makes recommendations regarding the following:
• When studies of PK in patients with impaired renal function should be performed and when they may be unnecessary
• The design and conduct of PK studies in patients with impaired renal function
• The design and conduct of PK studies in end-stage renal disease (ESRD) patients 60 undergoing dialysis (e.g., hemodialysis)
• The analysis and reporting of the results of such studies
• Representation of these results in the approved product labeling
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