Exposure Matching for Extrapolation of Efficacy in Pediatric Drug Development.

ABSTRACT: During drug development, matching adult systemic exposures of drugs is a common approach for dose selection in pediatric patients when efficacy is partially or fully extrapolated. This is a systematic review of approaches used for matching adult systemic exposures as the basis for dose selection in pediatric trials submitted to the US Food and Drug Administration (FDA) between 1998 and 2012. The trial design of pediatric pharmacokinetic (PK) studies and the pediatric and adult systemic exposure data were obtained from FDA publicly available databases containing reviews of pediatric trials. Exposure-matching approaches that were used as the basis for pediatric dose selection were reviewed. The PK data from the adult and pediatric populations were used to quantify exposure agreement between

SUBMITTER: Mulugeta Y 

PROVIDER: S-EPMC5482171 | biostudies-literature | 2016 Nov

REPOSITORIES: biostudies-literature