edited by Susan A. Griffiths and Cyndy E. Lumley

Considerable investment has been made by both pharmaceutical and biotechnology companies in pharmaceutical products of biotechnology. However, because relatively few of these products have been marketed, lack of relevant experience means that uncertainty still surrounds the most appropriate strategy for their safety evaluation.

Safety Evaluation of Biotechnologically-derived Pharmaceuticals: Facilitating a Scientific Approach not only describes safety evaluation recommendations, but also provides the reader with an appreciation of the science behind safety evaluation strategies used by experts, the influence of different regulatory systems on these strategies, and the type of data required by both toxicologists and clinicians before they have sufficient confidence to administer pharmaceutical products of biotechnology to humans.

Experts from Europe, Japan and the U.S.A. share safety evaluation programs for:

• colony stimulating factors
• growth factors
• hormones
• interferons
• interleukins
• monoclonal antibodies for therapeutic use
• gene therapy products

Contents

1. Designing Non-Clinical Safety Evaluation Programs: The View of the Clinician
2. Designing Non-Clinical Safety Evaluation Programs: The View of the Toxicologist
3. Company Strategies for Designing Non-Clinical Safety Evaluation Programs: Results of a CMR International Survey
4. Influence of Regulatory Systems: The U.S. FDA Perspective
5. Influence of Regulatory Systems: The European CPMP Perspective
6. Biotechnologically-Derived Pharmaceuticals in Japan: Present and Future Prospects
7. Designing Non-Clinical Safety Evaluation Programs for Colony Stimulating Factors, Growth Factors and Hormones: A Personal View
8. Designing Non-Clinical Safety Evaluation Programs for Colony Stimulating Factors, Growth Factors and Hormones: Recommendations and the Way Forward
9. Designing Non-Clinical Safety Evaluation Programs for Interferons and Interleukins: A Personal View
10. Designing Non-Clinical Safety Evaluation Programs for Interferons and Interleukins: Recommendations and the Way Forward
11. Designing Non-Clinical Safety Evaluation Programs for Monoclonal Antibodies for Therapeutic Use: A Personal View
12. Designing Non-Clinical Safety Evaluation Programs for Monoclonal Antibodies for Therapeutic Use: Recommendations and the Way Forward
13. Designing Non-Clinical Safety Evaluation Programs for Gene Therapy Products
14. Designing Non-Clinical Safety Evaluation Programs for Gene Therapy Products: Recommendations and the Way Forward

Index

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