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Safety Evaluation of Biotechnologically-Derived Pharmaceuticals: Facilitating a Scientific Approach
Cyndy E. Lumley
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Description for Safety Evaluation of Biotechnologically-Derived Pharmaceuticals: Facilitating a Scientific Approach
Hardcover. Includes proceedings that not only describe the recommendations but also provide the reader with an appreciation of the science behind safety evaluation strategies used by experts and the influence of different regulatory systems on these strategies. Editor(s): Griffiths, Susan A.; Lumley, Cyndy E. Series: Centre for Medicines Research Workshop. Num Pages: 200 pages, biography. BIC Classification: MMGT. Category: (P) Professional & Vocational. Dimension: 244 x 170 x 14. Weight in Grams: 498.
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. 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 ... Read more
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. 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 ... Read more
Product Details
Format
Hardback
Publication date
1998
Publisher
Springer
Condition
New
Series
Centre for Medicines Research Workshop
Number of Pages
200
Place of Publication
Dordrecht, Netherlands
ISBN
9780792387329
SKU
V9780792387329
Shipping Time
Usually ships in 15 to 20 working days
Ref
99-15
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