Angela James
Angela James is director, Astellas Pharma Global Development.
Articles
Extrapolating Data from Adult Clinical Trials to Advance Pediatric Drug Development
Sebastian Haertter;S. Y. Amy Cheung ;Angela James ;Ashley Strougo ;Christina Bucci-Rechtweg;Jing Liu ;Meina Tao Tang ;Paulien Ravenstijn ;Raafat Bishai ;Satyendra Suryawanshi ;Solange Corriol-Rohou
March 16th 2021Extrapolating data from adult clinical trials to a pediatric population is a proven method to avoid unnecessary pediatric clinical trials. Representatives of the Pediatric Working Group of the IQ Consortium share case studies that demonstrate how 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.
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