Drug and Biological Development

From Molecule to Product and Beyond

Ronald P. Evens (Herausgeber)

Media-Kombination
394 Seiten
2007 | 2007
Springer-Verlag New York Inc.
978-0-387-32978-9 (ISBN)

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Drug and Biological Development -
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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).
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.

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.

Zusatzinfo biography
Verlagsort New York, NY
Sprache englisch
Maße 210 x 279 mm
Themenwelt Medizin / Pharmazie Pharmazie
Technik
ISBN-10 0-387-32978-1 / 0387329781
ISBN-13 978-0-387-32978-9 / 9780387329789
Zustand Neuware
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