Clinical Development: Strategic, Pre-Clinical, and Regulatory Issues

Everyone involved in pre-clinical, clinical, formulation, development and regulatory affairs will find Clinical Development a valuable resource. The book provides expert advice on ways to reduce delays and lost market opportunities, minimize development time, better understand the process and regulatory requirements, and plan and analyze clinical development and testing programs. The author combines text, graphs, and charts to show how a company moves a product through the complex process from discovery to market. The result is a complete analysis of the drug development process in easy-to-understand language and easy-to-implement action steps.

About the Author

Janice Steiner founded Oxford Therapeutics Consulting Limited, a clinical consultancy, in 1992. Prior to establishing her own company, Dr. Steiner was Medical Director at Gensia Europe, Ltd., Director of Clinical Pharmacology at Searle Research and Development and Roche Products Ltd. Her experience includes all aspects of clinical trials including planning, executing, setting policy, and managing trials., The author of numerous publications, Dr. Steiner received a D. Phil. From Oxford University and an MBA from Middlesex Business School.