Drug and Biological Development From Molecule to Product and Beyond /
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...
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| Format: | Electronic eBook |
| Language: | English |
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Boston, MA :
Springer US,
2007.
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| Online Access: | Full Text via HEAL-Link |
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.
