Advanced Statistics in Regulatory Critical Clinical Initiatives

ISBN-13: 9780367561789 / Angielski / Twarda / 2022 / 307 str.

Opis

This book is focused on the critical clinical initiatives introduced by the 21st Century Cure Act passed by the United States Congress in December 2016. The book covers everything from the outline of the initiatives to analysis on the effect on biopharmaceutical research and development. 

Recenzje

"This is a must have book for any statistician working in the pharmaceutical industry that wants to have an introductory overview of the most recent and challenging issues and ongoing discussions in the field of statistical regulatory science."

David Manteigas, Cmed Clinical Services, Portugal, ISCB, February 2023

Spis treści

1  Introduction, 2  Complex Innovative Design, 3  Validation Strategy for Biomarker guided Precision/Personalized Medicine, 4 Model-Informed Drug Development, 5  Real-world data and real-world evidence, 6  AI/ML in Medical Research and Drug Development, 7 Challenges in Cancer Clinical Trials, 8  Statistical Methods for Assessment of Biosimilars, 9  Statistical Methods for Assessment of Complex Generic Drugs, 10  Rare Diseases Drug Development