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.

Biological products--United States.

Biological products.

Medical instruments and apparatus--United States.

Medical instruments and apparatus.

United States. Food and Drug Administration.

United States.

Physical Description:

1 online resource (233 p.)

Edition:

1st ed.

Place of Publication:

Hoboken, N.J. : Wiley, c2008.

Language Note:

English

Summary:

A step-by-step, integrated approach for successful, FDA-approved combination drug productsUsing 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 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:

Description based upon print version of record.

Includes bibliographical references and index.

Description based on metadata supplied by the publisher and other sources.

ISBN:

9786611381905

9781281381903

128138190X

9780470371077

0470371072

9780470371190

0470371196

OCLC:

476174850