Overview

This book offers a complete discussion of product development in the pharmaceutical and biotechnology industries from discovery, to product launch, through life cycle management. The book is organized for optimal usefulness in the education and training of health care professionals (MD, PharmD, PhD), at universities. The format is a set of figures, tables and lists, along with detailed narrative descriptions, including real-life examples, illustrations, controversies in industry, and references. The editors and authors of the book are industry and research experts in a variety of disciplines.

Full Product Details

Author:   Ronald P. Evens
Publisher:   Springer-Verlag New York Inc.
Imprint:   Springer-Verlag New York Inc.
Edition:   2007
Dimensions:   Width: 21.00cm , Height: 2.00cm , Length: 27.90cm
Weight:   1.293kg
ISBN:  

9780387329789

ISBN 10:   0387329781
Pages:   394
Publication Date:   01 August 2007
Audience:   College/higher education ,  Professional and scholarly ,  Undergraduate ,  Postgraduate, Research & Scholarly
Format:   Mixed media product
Publisher's Status:   Out of Print
Availability:   In Print  
Limited stock is available. It will be ordered for you and shipped pending supplier's limited stock.

Table of Contents

Health Care and Industry Overview and Challenges.- R&D Planning and Governance.- R&D Outcomes.- Discovery and Nonclinical Development.- Types of Clinical Studies.- Metabolism and Pharmacokinetics.- Laws and Regulations: The Discipline of Regulatory Affairs.- Clinical Trial Operations.- Formulation and Manufacturing.- Commercial Division.- Medical Affairs and Professional Services.- Special Considerations in Research.

Reviews

<p>From the reviews: <p><p> Drug and Biological Development: From Molecule to Product and Beyond covers drug development from portfolio planning through commercialization. The material combines strategic, managerial and operational perspectives. The book is ideal for anyone who wants to understand both the why and the how of the drug development and commercialization process. A CD-ROM is included that contains PowerPoint slides for each chapter, suitable for presentation to colleagues and students. (Norman M. Goldfarb, Journal of Clinical Research Best Practices, Vol. 4 (5), 2008)

From the reviews: <p> a ~Drug and Biological Development: From Molecule to Product and Beyonda (TM) covers drug development from portfolio planning through commercialization. The material combines strategic, managerial and operational perspectives. The book is ideal for anyone who wants to understand both the a ~whya (TM) and the a ~howa (TM) of the drug development and commercialization process. a ] A CD-ROM is included that contains PowerPoint slides for each chapter, suitable for presentation to colleagues and students. (Norman M. Goldfarb, Journal of Clinical Research Best Practices, Vol. 4 (5), 2008)

Author Information

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