Contract Research and Development Organizations PDF ePub eBook

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Contract Research and Development Organizations free pdf 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

About Shayne C. Gad

Shayne C. Gad, B.S. (Whittier College, Chemistry and Biology, 1970) and Ph.D. in Pharmacology/Toxicology (Texas, 1977) DABT, ATS, is the principal of Gad Consulting Services, an eighteen year old consulting firm with six employees and more than 450 clients (including 120 pharmaceutical companies in the US and 50 overseas). Prior to this, he served in director-level and above positions at Searle, Synergen and Becton Dickinson. He has published 41 books and more than 350 chapters, articles and abstracts in the fields of toxicology, statistics, pharmacology, drug development and safety assessment. He has more than 34 years of broad based experience in toxicology, drug and device development, statistics and risk assessment. He has specific expertise in neurotoxicology, in vitro methods, cardiovascular toxicology, inhalation toxicology, immunotoxicology, and genotoxicology. Past President of the American College of Toxicology, the Roundtable of Toxicology Consultants and three of SOT's specialty sections, and recipient of the American College of Toxicology Lifetime Contribution Award. He has direct involvement in the preparation of INDs (92 successfully to date), NDA, PLA, ANDA, 510(k), IDE, CTD, clinical data bases for phase 1 and 2 studies, and PMAs. He has consulted for FDA, EPA and NIH, and has trained reviewers and been an expert witness for FDA. He has also conducted the triennial toxicology salary survey as a service to the profession for the last 19 years. Charles 'Bart' Spainhour, V.M.D., Ph.D., DABT, DABFS, DABFM received his B.S. from Michigan State University, veterinary degree from the University of Pennsylvania and doctoral degree from Texas A

Details Book

Author : Shayne C. Gad
Publisher : Springer-Verlag New York Inc.
Data Published : 19 September 2014
ISBN : 148999890X
EAN : 9781489998903
Format Book : PDF, Epub, DOCx, TXT
Number of Pages : 212 pages
Age + : 15 years
Language : English
Rating :

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  • Contract Research and Development Organizations free pdfContract Research and Development Organizations

    . 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 o