Nonclinical Study Contracting and Monitoring

This book PDF is perfect for those who love Medical genre, written by William F. Salminen and published by Academic Press which was released on 31 December 2012 with total hardcover pages 262. You could read this book directly on your devices with pdf, epub and kindle format, check detail and related Nonclinical Study Contracting and Monitoring books below.

Nonclinical Study Contracting and Monitoring
Nonclinical Study Contracting and Monitoring
Author : William F. Salminen
File Size : 51,5 Mb
Publisher : Academic Press
Language : English
Release Date : 31 December 2012
ISBN : 9780123978318
Pages : 262 pages
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Nonclinical Study Contracting and Monitoring by William F. Salminen Book PDF Summary

Nonclinical Study Contracting and Monitoring: A Practical Guide offers a systematic and straightforward handbook for obtaining high quality preclinical Good Laboratory Practice (GLP) studies. This book is full of real-world examples, processes, procedures, useful templates, checklists and sample reports to provide readers with a better understanding of exactly what happens during all stages of a GLP study and the critical aspects of GLP study design and conduct. Designed for both the novice and experienced scientist, this book covers the GLP regulations and how they impact preclinical studies, the differences between GLP, non-GLP and peer-reviewed studies, preclinical GLP study design, laboratory selection, contracts and business ethics, how to obtain test material for the study, animal sourcing and release for study, preparation of a draft report and much more. By illustrating the overall big picture and tying it together with the individual steps, this book is an essential resource to help scientists ensure a high quality GLP study that passes both scientific and regulatory scrutiny. Includes both the "big picture" look at complex processes, such as contracting toxicology and safety studies with CROs, as well as a detailed account of each individual step. Contains several real world examples of problems in preclinical studies to provide you with an idea of the types of challenges that are routinely encountered and how this book can help you avoid these issues. Provides monitoring checklists through the book that will help you comply with each GLP requirement and maintain compliance throughout the entire process. Both entry level and experienced scientists involved in nonclinical toxicology study monitoring will benefit from the ideas, examples, discussions and strategies presented throughout this book.

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