| 书目名称 | Contract Research and Development Organizations | | 副标题 | Their Role in Global | | 编辑 | Shayne C. Gad,Charles B. Spainhour | | 视频video | | | 概述 | Covers the utilization of the full range of contract service providers throughout the process.This book is international in scope.Addresses the many new laws, regulations and the new REACH program gov | | 图书封面 |  | | 描述 | .The last 10 years have seen a seismic shift in therapeutic product development and testing. In both the pharmaceutical (both small and large molecule) and medical device sectors, the vast majority of testing and evaluation of products is not performed within innovator companies, but rather has been outsourced to a growing universe of commercial organizations. The authors both have more than 30 years experience in this field, and both have worked within innovator companies, for CROs, and as consultants in the field. .Contract Research and Development Organizations: Their Role in Global Product Development. has been crafted by these authors to provide a how to guide for all aspects of working with CROs in selecting, working with and ensuring the best possible desirable outcome of having the R&D function, or substantial parts of it, outsourced. It uses as the exemplary case nonclinical safety assessment, biocompatibility and efficacy testing which are to be performed to select the best possible candidate compound, device or formulation and then moving the resulting regulated therapeutic medical product into and through the development process and to marketing approval. But also co | | 出版日期 | Book 2011 | | 关键词 | Contract; Development; Gad; Research; Spainhour | | 版次 | 1 | | doi | https://doi.org/10.1007/978-1-4614-0049-3 | | isbn_softcover | 978-1-4899-9890-3 | | isbn_ebook | 978-1-4614-0049-3 | | copyright | Springer Science+Business Media, LLC 2011 |
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发表于 2025-3-21 17:58:12
