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- catalog abstract ""The 13th CMR International Workshop, held in February 1997, provided the opportunity for regulatory authority and industry experts from Europe, Japan and the USA to share their experiences of designing safety evaluation programmes for specific product classes: colony stimulating factors, growth factors, hormones, interferons, interleukins, monoclonal antibodies for therapeutic use, and gene therapy products. Participants worked together to recommend the studies that should be considered for safety evaluation of these biotechnology products and those that may be unnecessary."--Jacket.".
- catalog contributor b10999600.
- catalog contributor b10999601.
- catalog contributor b10999602.
- catalog created "c1998.".
- catalog date "1998".
- catalog date "c1998.".
- catalog dateCopyrighted "c1998.".
- catalog description ""The 13th CMR International Workshop, held in February 1997, provided the opportunity for regulatory authority and industry experts from Europe, Japan and the USA to share their experiences of designing safety evaluation programmes for specific product classes: colony stimulating factors, growth factors, hormones, interferons, interleukins, monoclonal antibodies for therapeutic use, and gene therapy products. Participants worked together to recommend the studies that should be considered for safety evaluation of these biotechnology products and those that may be unnecessary."--Jacket.".
- catalog description "Foreword / Giuseppe Vicari -- 1. Designing non-clinical safety evaluation programmes: The view of the clinician / John Lipani -- 2. Designing non-clinical safety evaluation programmes: The view of the toxicologist / Maggie Dempster -- 3. Company strategies for designing non-clinical safety evaluation programmes: Results of a CMR International survey / Susan Griffiths -- 4. Influence of regulatory systems: A viewpoint of the US FDA process / Joy A. Cavagnaro -- 5. Influence of regulatory systems: The European CPMP perspective / Per Sjoberg -- 6. Biotechnologically-derived pharmaceuticals in Japan: Present and future prospects / Tohru Inoue.".
- catalog description "Includes bibliographical references and index.".
- catalog extent "xviii, 200 p. :".
- catalog hasFormat "Safety evaluation of biotechnologically-derived pharmaceuticals.".
- catalog identifier "0792387325".
- catalog isFormatOf "Safety evaluation of biotechnologically-derived pharmaceuticals.".
- catalog isPartOf "CMR International workshop series".
- catalog isPartOf "CMR workshop series.".
- catalog issued "1998".
- catalog issued "c1998.".
- catalog language "eng".
- catalog publisher "Dordrecht ; Boston : Kluwer Academic Publishers,".
- catalog relation "Safety evaluation of biotechnologically-derived pharmaceuticals.".
- catalog subject "1999 C-757".
- catalog subject "615/.19 21".
- catalog subject "Biotechnology Congresses.".
- catalog subject "Biotechnology.".
- catalog subject "Drug Evaluation Congresses.".
- catalog subject "Drug Evaluation methods.".
- catalog subject "Drug Evaluation, Preclinical methods.".
- catalog subject "Drugs, Investigational toxicology.".
- catalog subject "Pharmaceutical biotechnology Safety measures Congresses.".
- catalog subject "Program Evaluation Congresses.".
- catalog subject "QV 771 C3972s 1998".
- catalog subject "RS380 .C46 1997".
- catalog subject "Safety Congresses.".
- catalog subject "Technology, Pharmaceutical methods.".
- catalog tableOfContents "Foreword / Giuseppe Vicari -- 1. Designing non-clinical safety evaluation programmes: The view of the clinician / John Lipani -- 2. Designing non-clinical safety evaluation programmes: The view of the toxicologist / Maggie Dempster -- 3. Company strategies for designing non-clinical safety evaluation programmes: Results of a CMR International survey / Susan Griffiths -- 4. Influence of regulatory systems: A viewpoint of the US FDA process / Joy A. Cavagnaro -- 5. Influence of regulatory systems: The European CPMP perspective / Per Sjoberg -- 6. Biotechnologically-derived pharmaceuticals in Japan: Present and future prospects / Tohru Inoue.".
- catalog 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.".
- catalog type "Conference proceedings. fast".
- catalog type "text".