Drug and Biological Development
From Molecule to Product and Beyond
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Beschreibung
Drug and Biological Development: From Molecule to Product and Beyond offers a complete discussion of product development in the pharmaceutical and biotechnology industries from discovery to product launch, continuing through life cycle management. The book is organized for optimal usefulness in the education and training of health care professionals. The text's narrative descriptions are enhanced by real-life examples, illustrations, controversies in industry, and references. Dr. Ronald Evens and his contributors are industry and research experts in a variety of disciplines.
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).
Ronald P. Evens Editors and Authors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 Editor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 Editorial Board . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 Chapter/Section Authors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 This book and CD-ROM contain an extensive discussion of for both public safety and health, industry regulation, and new product development in the pharmaceutical and biotechnol- product approvals. The needs, challenges, and controversies in ogy industries from discovery, to product launch, and through the industry are also addressed throughout the chapters. This life cycle management for the new researcher in academia or book shares how this success and the challenges are acc- industry. The primary goal is the education of new researchers plished by the various groups of specialized people, with all in the academic medical center and industry environments the organization requirements, in compliance with the many about industry-based research and product development. The laws and regulations, and with the many processes and o- perspective is product development (drugs and biologicals) comes necessary from each contributing industry department. especially from the industry situation, along with collabora- This preface and introduction to the book provides a d- tion with medical center scientists. References are quite cussion on the needs and use for the book, brief biographies extensive to support the work, numbering more than 500. The of the editorial board, a brief description of each of the authors collectively have several hundred years of experience authors, acknowledgments, and a list of key information at senior levels in product development in the industry or sources about the industry and related information.
No single book employs both a format designed for fellows’ and residents’ education and covers the full scope of drug development from discovery through a product’s life cycle
The unique features of this book are several-fold: the dual narrative - slide design, which is a user friendly format for fellows and faculty (book), research controversies being addressed, real life examples being addressed, up-to-date material, general information section for each chapter for non-experts, detail information sections for depth as needed, and expert industry and research authors
Extensive and hands-on experiences of the authors and editors in the product development and research both in the industry and academia, as well as their multidisciplinary backgrounds
This book touches on a complete range of topics, from early research to post-marketing; health care issues impacting product development; organization and planning; marketing role in research; and the 5 special therapeutic areas
The book is a complete discussion of product development in the pharmaceutical and biotechnology industries from discovery, to product launch, and through life cycle management. No single book employs both a format designed for fellows’ and residents’ education and covers the full scope of drug development from discovery through a product’s life cycle. The format is a set of figures, tables and lists that can become power-point style slides, and there are detailed narrative descriptions, including real-life examples, illustrations, controversies in industry, and references. The book is authored and edited by industry and research experts.
Autor*in
Ronald Evens
Themen in »Drug and Biological Development«
Biological Development Drugs Evens Molecule infectious disease metabolism
Stimmen zu »Drug and Biological Development«
From the reviews:"‘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." (Norman M. Goldfarb, Journal of Clinical Research Best Practices, Vol. 4 (5), 2008)
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