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Titlebook: Contract Research and Development Organizations-Their History, Selection, and Utilization; Shayne C. Gad,Charles B. Spainhour,David G. Ser

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发表于 2025-3-21 18:23:45 | 显示全部楼层 |阅读模式
书目名称Contract Research and Development Organizations-Their History, Selection, and Utilization
编辑Shayne C. Gad,Charles B. Spainhour,David G. Serota
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概述Addresses the history of CROs, including snapshots of CROs and a genealogy chart making clear where they came from and where they went.Essential for pharmaceutical and medical device study directors a
图书封面Titlebook: Contract Research and Development Organizations-Their History, Selection, and Utilization;  Shayne C. Gad,Charles B. Spainhour,David G. Ser
描述.This volume provides a complete update of all the materials in prior volumes on the subject (including current directories to testing labs and other support establishments worldwide), while adding substantial new material on the following topics:..·        The history of CROs, including snapshots of CROs and a genealogy chart making clear where they came from and where they went...·        Study directors and principal investigators...·        The nuts and bolts of study performance...·        Electronic reporting requirements – SEND and eCTD (required for NDA, BLA, ANDA, and IND submissions)...·        Consultants and their roles...·        An expanded examination of common problems and their solutions. ..This book boastscomplete directories to the global universe of operating labs – where they are, how to contact them, and what they do (including special capabilities). Additionally, checklists for qualifying labs and manufacturing facilities – and for auditing studies and projects at such facilities – are included. It is directed at those in industry (specifically directed at those working for companies using CRO services) but will also be of interest to scientists or administra
出版日期Book 2020
关键词CROs; Pharmaceutical consultants; Pharmaceutical and medical device Product Development; Pharmaceutical
版次1
doihttps://doi.org/10.1007/978-3-030-43073-3
isbn_softcover978-3-030-43075-7
isbn_ebook978-3-030-43073-3
copyrightSpringer Nature Switzerland AG 2020
The information of publication is updating

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Christine Ettrich,Klaus Udo Ettrichn be done is to be aware of the potential of such problems and to be prepared to solve them if they arise. Preferably the initial step to a solution is knowledge of how others have previously solved similar problems so that one can only de novo solve the new ones.
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Common Problems and Solutions,n be done is to be aware of the potential of such problems and to be prepared to solve them if they arise. Preferably the initial step to a solution is knowledge of how others have previously solved similar problems so that one can only de novo solve the new ones.
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Upper Limb Arterial Intervention,pects of the body, all orifices; the cranial, thoracic, abdominal, and pelvic cavities and their contents; and the musculature, subcutis, and bone. However, gross observations only types of necropsies can also be performed depending upon the type of study, the objective of the study, or the limitations set by the protocol and the sponsor.
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Verhaltensauffällige Kinder und Jugendlichehat can impede that relationship. In many cases, these roadblocks emanate from the absence of clear and concise communication and processes that need to be developed and followed between both parties to ensure that both parties are on the same path.
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Optimizing Your Experience and Relationship with Your Preclinical CRO,hat can impede that relationship. In many cases, these roadblocks emanate from the absence of clear and concise communication and processes that need to be developed and followed between both parties to ensure that both parties are on the same path.
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