Safety Evaluation of Biotechnologically-derived Pharmaceuticals

Preface. Foreword. 1. Designing Non-Clinical Safety Evaluation Programmes: The View of the Clinician; J. Lipani. 2. Designing Non-Clinical Safety Evaluation Programmes: The View of the Toxicologist; M. Dempster. 3. Company Strategies for Designing Non-Clinical Safety Evaluation Programmes: Results of a CMR International Survey; S. Griffiths. 4. Influence of Regulatory Systems: The U.S. FDA Perspective; J. Cavagnaro. 5. Influence of Regulatory Systems: The European CPMP Perspective; P. Sjöberg. 6. Biotechnologically-Derived Pharmaceuticals in Japan: Present and Future Prospects; T. Inoue. 7. Designing Non-Clinical Safety Evaluation Programmes for Colony Stimulating Factors, Growth Factors and Hormones: A Personal View; D. Morton. 8. Designing Non-Clinical Safety Evaluation Programmes for Colony Stimulating Factors, Growth Factors and Hormones: Recommendations and the Way Forward; J. Sims, F. De la Iglesia. 9. Designing Non-Clinical Safety Evaluation Programmes for Interferons and Interleukins: A Personal View; D. Johnson. 10. Designing Non-Clinical Safety Evaluation Programmes for Interferons and Interleukins: Recommendations and the Way Forward; J. Cavagnaro, T. Anderson. 11. Designing Non-Clinical Safety Evaluation Programmes for Monoclonal Antibodies for Therapeutic Use: A Personal View; P. Bugelski. 12. Designing Non-Clinical Safety Evaluation Programmes for Monoclonal Antibodies for Therapeutic Use: Recommendations and the Way Forward; J. Green, J. Purves. 13. Designing Non-Clinical Safety Evaluation Programmes for Gene Therapy Products: A Personal View; J. MacDonald.14. Designing Non-Clinical Safety Evaluation Programmes for Gene Therapy Products: Recommendations and the Way Forward; P. Harris, A. Dayan. Index.