| 书目名称 | Safety Evaluation of Biotechnologically-derived Pharmaceuticals | | 副标题 | Facilitating a Scien | | 编辑 | Susan A. Griffiths,Cyndy E. Lumley | | 视频video | | | 丛书名称 | Centre for Medicines Research Workshop | | 图书封面 |  | | 描述 | Considerable investment has been made by both pharmaceuticaland biotechnology companies in pharmaceutical products ofbiotechnology. However, because relatively few of these products havebeen marketed, lack of relevant experience means that uncertaintystill surrounds the most appropriate strategy for their safetyevaluation. The 13th CMR International Workshop, held in February1997, provided the opportunity for regulatory authority and industryexperts from Europe, Japan and the USA to share their experiences ofdesigning safety evaluation programmes for specific product classes:colony stimulating factors, growth factors, hormones, interferons,interleukins, monoclonal antibodies for therapeutic use, and genetherapy products. Participants worked together to recommend thosestudies that should be considered for such safety evaluation, andthose that may be unnecessary. These recommendations subsequently madea valuable contribution to the ICH guideline `Safety Studies forBiotechnological Products‘, which was finalised at ICH 4 in Brusselsin July 1997. The Workshop proceedings not only describe therecommendations but also provide the reader with an appreciation ofthe science behind safety ev | | 出版日期 | Book 1998 | | 关键词 | biotechnology; gene therapy; growth factor; interferon; research | | 版次 | 1 | | doi | https://doi.org/10.1007/978-94-011-4876-4 | | isbn_softcover | 978-94-010-6043-1 | | isbn_ebook | 978-94-011-4876-4 | | copyright | Springer Science+Business Media Dordrecht 1998 |
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发表于 2025-3-21 19:15:52
