Drug and Biological Development: From Molecule to Product and Beyond

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Ronald Evens
Springer Science & Business Media, Aug 14, 2007 - Medical - 382 pages
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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.
 

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Contents

Introduction
1
RD Planning and Governance
33
RD Outcomes
66
3
76
Discovery and Nonclinical Development
84
Types of Clinical Studies
107
Metabolism and Pharmacokinetics
123
The Discipline of Regulatory Affairs
148
Practical Approaches
235
Departmental Issues
241
Pipeline Product Information
247
Medical Communications
256
Special Considerations in Research
275
Conclusions
290
Proposed Approaches to Address Bad Bugs NO Drugs
306
References
319

Clinical Trial Operations
178
9
202
Commercial Division
222
Commercialization Process
228
The Science in Pediatric and Clinical Studies
333
Appendix 1
351
Appendix 2
366
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