Angela James

home / authors / angela-james

Angela James is director, Astellas Pharma Global Development.

Articles

Extrapolating Data from Adult Clinical Trials to Advance Pediatric Drug Development

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 2021

Extrapolating 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.

Latest Updated Articles

Buy, Sell, Hold: Cell and Gene Therapy
Published: October 11th 2024 | Updated: October 18th 2024
Buy, Sell, Hold: Cell and Gene Therapy - Part 1
Text sign showing Industry News. Business photo text delivering news to the general public or a target public | Image Credit: © Artur - © Artur - stock.adobe.com
Published: September 10th 2024 | Updated: September 18th 2024
CPHI Milan Announces 2024 CPHI Pharma Award Finalists
Published: October 28th 2024 | Updated: November 25th 2024
Discovery to Commercialization: The Right Partnerships are Key to Streamlined Drug Development
Operator work on infusion pharmaceutical industry | Image Credit: © xmagics - © xmagics - stock.adobe.com
Published: November 6th 2024 | Updated: November 25th 2024
Automate Aseptic Filling: Closing the System at Full Modularity
Two scientists wearing lab coats and safety glasses analyzing data displayed on a computer screen in a laboratory setting | Image Credit: © NCST Studio - © NCST Studio - stock.adobe.com
Published: November 5th 2024 | Updated: November 25th 2024
Untethered Data: Unifying and Contextualizing Drug Discovery Data
Medium shot of female process supervisor in lab coat pointing at equipment controlling production quality with African American male manufacturing technician, working in protective suit at factory | Image Credit: © Seventyfour - © Seventyfour - stock.adobe.com
Published: November 8th 2024 | Updated: November 25th 2024
Application of Validation Principles to the Training Quality System: Part 9, Quality Risk Management Hazard Identification