BioPharm International - March 2021

BioPharm International - Regulatory Sourcebook - March 2021

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Page 30 of 47 March 2021 eBook BioPharm International 31 Extrapolating Data from Adult Clinical Trials to Advance Pediatric Drug Development Adult clinical trial data can be used to support the dose selection and regimen—or waive the need for a placebo control arm —for pediatric studies. E xtrapolation to the pediatric population using available data obtained from a reference population is a well-recognized approach to achieve more efficient pediatric drug devel- opment and avoid unnecessary pediatric clin- ical trials. While regulations regarding the use of extrapolation date back to 1994 (1), there are still sig- nificant challenges in the implementation of pediatric extrapolation (2–4). To ensure the "voice of industry" was heard as the regulatory landscape evolved, the Clinical Pharmacology Leader Group (CPLG) of the IQ Consortium (IQ) established the Pediatric Working Group (PWG) in 2011, and it has evolved to be an integral part of the implementation and dissemination of the use of extrapolation as a framework to optimize the develop- ment of therapeutics for pediatric use. The PWG currently consists of 38 members from 24 different organizations, and includes representatives from IQ corporate members, regulatory agencies, and non-IQ member companies to strengthen its diversity in expertise and perspective on pediatric drug devel- opment. In collaboration with the pharmaceutical industry, regulatory agencies, academia, and non-profit organizations, the PWG has organized/co-organized Paulista - Sebastian Haertter, S.Y. Amy Cheung, Angela James, Ashley Strougo, Christina Bucci-Rechtweg, Jing Liu, Meina Tao Tang, Paulien Ravenstijn, Raafat Bishai, Satyendra Suryawanshi, and Solange Corriol-Rohou; all authors are members of the IQ Consortium. Regulatory Sourcebook Quality Collaboration

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