Pediatric Pharmacokinetic Study Quality Standard Needs Rethinking, Cmte. Tells FDA
Executive Summary
The Advisory Committee for Pharmaceutical Science and Clinical Pharmacology rejects FDA’s proposed standard, which the agency and sponsors have been operating under for six months, for deriving the sample size in pediatric PK trials. The agency’s approach does not offer enough flexibility and may not fit all pediatric PK study programs, committee members said.
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