Nonclinical Study Contracting and Monitoring

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Nonclinical Study Contracting and Monitoring: A Practical Guide offers a systematic and straightforward handbook for obtaining high-quality preclinical 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 the novice and experienced scientist, this book covers the GLP regulations and how they impact preclinical studies, the differences among 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.

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