Abstract #302213

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JSM 2003 Abstract #302213
Activity Number: 211
Type: Contributed
Date/Time: Tuesday, August 5, 2003 : 8:30 AM to 10:20 AM
Sponsor: Biopharmaceutical Section
Abstract - #302213
Title: Statistical Approaches to the Analysis of Effects of Renal Impairment on Pharmacokinetics of Drugs
Author(s): Robert A. Smith*+
Companies: Bristol-Myers Squibb Company
Address: 11 Bayberry Rd., Princeton, NJ, 08540-7418,
Keywords: biopharmaceutics ; pharmacokinetics ; renal impairment
Abstract:

Studies of the effects of renal impairment on the pharmacokinetics of drugs are standard clinical trials in most drug development programs, so much so that in 1998, the Food and Drug Administration issued a Guidance to Industry on the subject. Since creatinine clearance (CLcr) is an accepted marker for renal function, the usual statistical approaches involve regressing measures of pharmacokinetic exposure (dose normalized Cmax and AUC) or clearance on CLcr. This paper looks at some of the statistical approaches used to analyze data from recently reported renal impairment studies and recommends an approach that is consistent with the way clinical pharmacokinetic data are usually handled and lends itself to testing for absence of effect.

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