Siegel Development and Approval of Combination Products

A Regulatory Perspective
1. Auflage 2008
ISBN: 978-0-470-37119-0
Verlag: John Wiley & Sons
Format: PDF
Kopierschutz: Adobe DRM (»Systemvoraussetzungen)

E-Book, Englisch, 240 Seiten, E-Book

A step-by-step, integrated approach for successful, FDA-approvedcombination drug products
Using a proven integrated approach to combination drug development,this book guides you step by step through all the preclinical,clinical, and manufacturing stages. Written from an FDA regulatoryperspective, the book not only enables you to bring a successfulcombination drug product to market, it also sets forth the mostefficient and effective path to FDA approval.
The book begins with an introductory chapter presenting definitionsand basic regulatory principles of combination products. Next, itreviews manufacturing and controls, preclinical testing models,pharmacology, clinical testing, regulatory submissions, FDAreviews, and approvals. Among the key topics examined are:
* The pharmacology, safety pharmacology, and toxicology supportinghuman clinical trials of combination products
* Approaches to clinical trial protocol design and execution
* Chemical, physicochemical, and analytical aspects ofmanufacturing controls and validation that lead to stablecomponents for combination products
* Key sponsor/FDA meetings and negotiations essential for approvaland commercialization
Case studies involving such actual combination products asMylotarg, Herceptin, and HercepTest help you better understand howto implement the author's practical guidelines. References at theend of each chapter enable you to find more information on anystage of the development, manufacturing and approvalprocesses.
This book is ideal for researchers, regulators, academics, projectmanagers, and executives involved in the complex process ofcombination product development. Not only does itoffer acomprehensive guide to the technical aspects of the field, it alsointegrates all ofthese technical aspects into a unified, effectiveapproach to help ensure a successful, approved product.

Autoren/Hrsg.

Siegel, Evan B.

Über Autor(innen)

Evan B. Siegel, PhD, is President and CEO of Ground Zero Pharmaceuticals, Inc., and an Adjunct Professor at the University of Queensland in Australia. Dr. Siegel has held positions as a Toxicology Reviewer at the U.S. Food and Drug Administration and Supervising Toxicologist in the California Department of Health Services. He has also served in regulatory affairs and executive positions in CROs, the pharmaceutical industry, and trade associations. In addition, Dr. Siegel was an editor of Regulatory Affairs Focus from 1999 to 2001.