Drug and Biological Development offers a complete discussion of product development in the pharmaceutical and biotechnology industries from discovery to product launch, continuing through life cycle management.

Drug and Biological Development is organized for optimal usefulness in the education and training of health care professionals.

Contents

1. Health Care and Industry Overview and Challenges
2. R&D Planning and Governance
3. R&D Outcomes
4. Discovery and Nonclinical Development
5. Types of Clinical Studies
6. Metabolism and Pharmacokinetics
7. Laws and Regulations: The Discipline of Regulatory Affairs
8. Clinical Trial Operations
9. Formulation and Manufacturing
10. Commerical Division
11. Medical Affairs and Professional Services
12. Special Considerations in Research

Index

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