By Dennis Stephens, Helen Williams, Megan McMahon, Fenghe Qiu, Cherokee Hoaglund Hyzer, Elke Debie, Yan Wu, Hanlin Li, Jin Wang
Published in: Pharmaceutical Technology 42(8):42–47
Published on: August 1, 2018
A published regulatory template sharing best practices for filing RBPS data would benefit the industry and regulatory reviewers by enabling a consistent presentation of predictive data and conclusions.
Key Words: Model, Extension, Q1A