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FDA scientific investigations are beginning to review toxicokinetic studies.

Executive Summary

CDER REVIEWING TOXICOKINETIC STUDIES FOR DATA INTEGRITY, FDA Center for Drug Evaluation & Research Scientific Investigations Division Associate Director C.T. Viswanathan, PhD, told a Nov. 20 agency/industry discussion group on pharmaceutical laboratory practices in Rockville, Md. As part of FDA's Bioequivalence Inspection Program the agency has "already started looking into toxicokinetic studies," Viswanathan said. We're looking for data integrity of the toxicokinetic studies. It is very parallel to pharmacokinetic studies."
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