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Nonclinical study contracting and monitoring : a practical guide

Author: William F Salminen; Joe M Fowler; James Greenhaw
Publisher: Amsterdam : Elsevier Science/AP, ©2013.
Edition/Format:   Print book : EnglishView all editions and formats
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  Read more...
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Document Type: Book
All Authors / Contributors: William F Salminen; Joe M Fowler; James Greenhaw
ISBN: 9780123978295 0123978297
OCLC Number: 839920805
Description: xi, 249 pages : illustrations
Contents: Front Cover; Nonclinical Study Contracting and Monitoring: A Practical Guide; Copyright; Contents; List of Contributors; Chapter 1 --
Introduction; Key Points; GLPS and Nonclinical studies ; Cros and Nonclinical studies : study directors ; examples of study issues ; conclusion ; Chapter 2 --
Good Laboratory Practices; Key Points; US FDA (21 CFR part 58) And OECD GLPS; Subpart A --
General provisions ; subpart B --
Organization and personnel ; subpart C --
Facilities ; subpart D --
Equipment ; subpart E --
Testing facilities operation ; subpart F --
Test and control articles. Subpart G --
Protocol for and conduct of a nonclinical laboratory study subpart J --
Recrods and reports ; GLP Facility inspections ; GLP auditing checklist ; Chapter 3 --
Study Design; Key Points; General study design issues ; study design checklist ; Chapter 4 --
Animal Welfare; Key Points; The "Guide"; Regulations established by the USDA under the AWA; Potential conflicts between the animal welfare requirements, GLPS, and other study requirements ; animal welfare checklist ; Chapter 5 --
Laboratory Selection; Key Points; Contacting and preliminary screening of a new laboratory. Visiting and auditing a new laboratory ; Laboratory selection checklist ; Chapter 6 --
Project Proposal; Key Points; Detailed study outline ; price negotiation ; detailed study outline template ; Chapter 7 --
Contracts and Business Ethics; Confidentiality ; Key Points; Contracts ; maintaining confidentiality during the study ; business ethics ; example of a confidential disclosure agreemrnt ; Chapter 8 --
Study Protocol Preparation, Review, and Approval; Key Points; Writing the first draft ; reviewing the draft protocol ; finalizing the protocol ; changing the finalized protocol ; protocol checklist. Chapter 9 --
Test Article ; test and control article synthesis and sourcing ; Key points; test and control article characterization ; mixtures of test articles ; test article and mixture receipt, storage, and tracking ; additional considerations ; Chapter 10 --
Study Start Through End of In-Life; test article and formulations ; Key Points; acquring animals ; pre-study meeting ; first day of dosing, protocol deviations and amendments ; study updates, data auditing, and GLP compliance; necropsy ; Chapter 11 --
Study Communication and Data Management; Key Points; handling issues that may arisre; data management. Study reports and archiving, communicating study results ; study audit template ; Chapter 12 --
A Study Director's Perspective on Study Monitor-Study Director Interactions; establishing the working relationship ; Key Points; setting your expectations ; the study director's expectations of you ; pre-protocol communications ; protocol development ; the pre-study meeting ; visiting the laboratory ; study updates ; study issues and the unexpected ; reporting ; conclusions ; Chapter 13 --
Draft Report; Key Points; setting expectations ; receiving the draft report ; sending comments to the laboratory ; summary. Chapter 14 --
Final Report, Study Close-Out, and Conclusions.
Responsibility: edited by William F. Salminen, Joe M. Fowler, James Greenhaw.

Abstract:

A handbook for obtaining high quality preclinical Good Laboratory Practice (GLP) studies. It provides readers with a better understanding of exactly what happens during all stages of a GLP study and  Read more...

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"I particularly liked the detailed checklists that are provided throughout the book...this book is an excellent practical guide on how to perform, contract, monitor and report nonclinical studies. Read more...

 
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