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Book
Author CMR International Workshop (1997 : Wych Cross, England)

Title Safety evaluation of biotechnologically-derived pharmaceuticals : facilitating a scientific approach : proceedings of a CMR International Workshop held at Ashdown Park Hotel, Wych Cross, UK, February 1997 / edited by Susan A. Griffiths and Cyndy E. Lumley
Published Dordrecht ; Boston : Kluwer Academic Publishers, [1998]
©1998

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Location Call no. Vol. Availability
 MELB  615.19 Cen/Seo  AVAILABLE
Description xviii, 200 pages : illustrations ; 24 cm
Series CMR International workshop series
CMR workshop series.
Contents Machine derived contents note: 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. Sjḇerg. 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
Bibliography Includes bibliographical references and index
Subject Pharmaceutical biotechnology -- Safety measures -- Congresses.
Genre/Form Conference papers and proceedings.
Author Griffiths, Susan A.
Lumley, C. E. (Cindy E.)
LC no. 98196381
ISBN 0792387325