Safety Evaluation of Biotechnologically-derived Pharmaceuticals

1 Designing non-clinical safety evaluation programmes: The view of the clinician.- 2 Designing non-clinical safety evaluation programmes: The view of the toxicologist.- 3 Company strategies for designing non-clinical safety evaluation programmes: Results of a CMR International survey.- 4 Influence of regulatory systems: A viewpoint of the US FDA process.- 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 programmes for colony stimulating factors, growth factors and hormones: A personal view.- 8 Designing non-clinical safety evaluation programmes for interferons and interleukins: A personal view.- 9 Designing non-clinical safety evaluation programmes for monoclonal antibodies for therapeutic use: A personal view.- 10 Designing non-clinical safety evaluation programmes for gene therapy products: A personal view.- 11 Recommendations and the way forward.- 12 Designing non-clinical safety evaluation programmes for colony stimulating factors, growth factors and hormones: Recommendations and the way forward.- 13 Designing non-clinical safety evaluation programmes for interferons and interleukins: Past experiences and recommendations for future products.- 14 Designing non-clinical safety evaluation programmes for monoclonal antibodies: Recommendations and the way forward.- 15 Designing a safety evaluation programme for gene therapy products: Recommendations and the way forward.- Appendix I: Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals: ICH Step 4 Harmonised Tripartite Guideline.- Appendix II: List of Participants.