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

PB2000101512

Publication Date	1998
Page Count	17
Abstract	This guidance is intended for sponsors who, during the investigational phase of drug development, plan to conduct studies to assess the influence of renal impairment on the pharmacokinetics of an investigational drug. This guidance makes recommendations regarding: when studies of PK in patients with impaired renal function should be performed--and conversely, when they may be unecessary; 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 treated with dialysis (hemodialysis or peritoneal dialysis); the analysis and reporting of the results of such studies; and representation of these results in approved product labeling.
Keywords	Labeling Drugs Pharmacokinetics Renal function Pharmacology Drug industry Patients Regulations Document guidance Data analysis Investigations Liver Metabolism Medical research Product labeling Food and Drug Administration
Source Agency	Food and Drug Administration
Corporate Authors	Food and Drug Administration, Rockville, MD.
Document Type	Technical Report
NTIS Issue Number	200007

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

Guidance for Industry. Pharmacokinetics in Patients with Impaired Renal Function Study Design, Data Analysis, and Impact on Dosing and Labeling.
PB2000101512

Publication Date	1998
Page Count	17
Abstract	This guidance is intended for sponsors who, during the investigational phase of drug development, plan to conduct studies to assess the influence of renal impairment on the pharmacokinetics of an investigational drug. This guidance makes recommendations regarding: when studies of PK in patients with impaired renal function should be performed--and conversely, when they may be unecessary; 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 treated with dialysis (hemodialysis or peritoneal dialysis); the analysis and reporting of the results of such studies; and representation of these results in approved product labeling.
Keywords	Labeling Drugs Pharmacokinetics Renal function Pharmacology Drug industry Patients Regulations Document guidance Data analysis Investigations Liver Metabolism Medical research Product labeling Food and Drug Administration
Source Agency	Food and Drug Administration
Corporate Authors	Food and Drug Administration, Rockville, MD.
Document Type	Technical Report
NTIS Issue Number	200007