{"product_id":"9780792387329","title":"Centre for Medicines Research Workshop: Facilitating a Scientific Approach","description":"\u003ch1\u003eCentre for Medicines Research Workshop: Facilitating a Scientific Approach\u003c\/h1\u003e \u003ch2\u003eGriffiths, Susan A.; Lumley, C.\u003c\/h2\u003e \u003cp\u003eConsiderable 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 for therapeutic use, and gene  therapy products. Participants worked together to recommend those  studies that should be considered for such safety evaluation, and  those that may be unnecessary. These recommendations subsequently made  a valuable contribution to the ICH guideline `Safety Studies for  Biotechnological Products', which was finalised at ICH 4 in Brussels  in July 1997. The Workshop proceedings not only describe the  recommendations but also provide the reader with an appreciation of  the science behind safety evaluation strategies used by experts, the  influence of different regulatory systems on these strategies, and the  type of data required by both toxicologists and clinicians before they  have sufficient confidence to administer pharmaceutical products of  biotechnology to humans.\u003c\/p\u003e \u003ch3\u003eDetails\u003c\/h3\u003e \u003cp\u003ePublished by: Springer\u003c\/p\u003e \u003cp\u003ePublication Date: 1998-06-30\u003c\/p\u003e \u003cp\u003eFormat: Hardcover\u003c\/p\u003e \u003cp\u003eISBN-13: 9780792387329\u003c\/p\u003e \u003cp\u003eDOI: 10.1007\/978-94-011-4876-4\u003c\/p\u003e \u003cp\u003eDimensions: 244cm x170cm\u003c\/p\u003e \u003cp\u003ePages: 200\u003c\/p\u003e ","brand":"Springer Netherlands","offers":[{"title":"Default Title","offer_id":44541612982412,"sku":"9780792387329","price":98.99,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0710\/9545\/1788\/files\/9780792387329.jpg?v=1771516942","url":"https:\/\/lateknightbooks.com\/products\/9780792387329","provider":"Late Knight Books and Services, LLC","version":"1.0","type":"link"}