Development and approval of combination products : a regulatory perspective / edited by Evan B. Siegel.

Format:

Book

Contributor:

Siegel, Evan B.

Language:

English

Subjects (All):

Drug approval--United States.

Drug approval.

Medical instruments and apparatus.

Biological products.

United States.

Biological products--United States.

Medical instruments and apparatus--United States.

United States. Food and Drug Administration.

Drug Approval--legislation & jurisprudence.

Drug Combinations.

Device Approval--legislation & jurisprudence.

Medical Subjects:

Drug Approval--legislation & jurisprudence.

United States.

Drug Combinations.

Device Approval--legislation & jurisprudence.

Physical Description:

xii, 215 pages : illustrations ; 25 cm

Place of Publication:

Hoboken, N.J. : Wiley, [2008]

Summary:

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 regulatory perspective, the book not only enables you to bring a successful combination drug product to market, it also sets forth the most efficient and effective path to FDA approval.

The book begins with an introductory chapter presenting definitions and basic regulatory principles of combination products. Next, it reviews manufacturing and controls, preclinical testing models, pharmacology, clinical testing, regulatory submissions, FDA reviews, and approvals. Among the key topics examined are: The pharmacology, safety pharmacology, and toxicology supporting human clinical trials of combination products, Approaches to clinical trial protocol design and execution, Chemical, physicochemical, and analytical aspects of manufacturing controls and validation that lead to stable components for combination products, Key sponsor/FDA meetings and negotiations essential for approval and commercialization.

Case studies involving such actual combination products as Mylotarg, Herceptin, and HercepTest help you better understand how to implement the author's practical guidelines. References at the end of each chapter enble you to find more information on any stage of the development, manufacturing and approval processes.

This book is ideal for researchers, regulators, academics, project managers, and executives involved in the complex process of combination product development. Not only does it offer a comprehensive guide to the technical aspects of the field, it also integrates all of these technical aspects into a unified, effective approach to help ensure a successful, approved product.

Contents:

Overview of combination products development and regulatory review / Evan B. Siegel

Detailed regulatory approaches to development, review, and approval / James Barquest

Nonclinical recommendations for successful characterization and development of combination drug products / Duane B. Lakings

Clinical pharmacology and clinical development of combination products / Chaline Brown

Regulatory strategy considerations for chemistry, manufacturing, and controls: an integrated approach / Patrick L. DeVillier.

Notes:

Includes bibliographical references and index.

ISBN:

9780470050941

0470050942

OCLC:

190867380

Online:

Publisher description

Contributor biographical information