Pharmacokinetics in Patients with Impaired Renal Function Study Design Data Analysis and Impact on Dosing and Labeling Guidance 1998

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 PK of an investigational drug. Topics covered in this guidance are: deciding whether to conduct a study in patients with impaired renal function (when studies may be important, when studies may not be important); study design (basic "full" study design, reduced/staged study design, population PK studies, effect of dialysis on PK, PD assessments); data analysis (parameter estimation, modeling the relationship between renal function and PK, development of dosing recommendations); and labeling (clinical pharmacology, precautions/warnings, dosage and administration, overdosage).

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