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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.
Toxicologists in pharmaceutical, agrochemical, food additive and industrial chemical industries, as well as study monitors, quality assurance unit (QUA) personnel, and other scientists who are responsible for contracting preclinical GLP studies with CROS and internal company laboratories.
List of Contributors
Chapter 1. Introduction
GLPs and Nonclinical Studies
CROs and Nonclinical Studies
Examples of Study Issues
Chapter 2. Good Laboratory Practices
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 – Records and Reports
GLP Facility Inspections
GLP Auditing Checklist
Chapter 3. Study Design
General Study Design Issues
Study Design Checklist
Chapter 4. Animal Welfare
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
Contacting and Preliminary Screening of a New Laboratory
Visiting and Auditing a New Laboratory
Laboratory Selection Checklist
Chapter 6. Project Proposal
Detailed Study Outline
Detailed Study Outline Template
Chapter 7. Contracts and Business Ethics
Maintaining Confidentiality During the Study
Example of a Confidential Disclosure Agreement
Chapter 8. Study Protocol Preparation, Review, and Approval
Writing the First Draft
Reviewing the Draft Protocol
Finalizing the Protocol
Changing the Finalized Protocol
Chapter 9. Test Article
Test and Control Article Synthesis and Sourcing
Test and Control Article Characterization
Mixtures of Test Articles
Test Article and Mixture Receipt, Storage, and Tracking
Chapter 10. Study Start Through End of In-Life
Test Article and Formulations
First Day of Dosing
Protocol Deviations and Amendments
Study Updates, Data Auditing, and GLP Compliance
Chapter 11. Study Communication and Data Management
Handling Issues that may Arise
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
Setting Your Expectations
The Study Director’s Expectations of You
The Pre-Study Meeting
Visiting the Laboratory
Study Issues and the Unexpected
Chapter 13. Draft Report
Receiving the Draft Report
Sending Comments to the Laboratory
Chapter 14. Final Report, Study Close-Out, and Conclusions
Finalizing the Report
Amending the Final Report
- No. of pages:
- © Academic Press 2013
- 31st December 2012
- Academic Press
- Paperback ISBN:
- eBook ISBN:
PhD, DABT, PMP, PAREXEL International, Benton, AR
BS, RQAP-GLP, Director of the Quality Assurance Unit, National Center for Toxicological Research, FDA, Jefferson, AR
BS, LAT, Director of the Quality Assurance Unit, National Center for Toxicological Research, FDA, Jefferson, AR
"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. It is well presented and easy to read and will be particularly useful for beginning study monitors and toxicologists."--British Toxicology Society, Issue 43, Winter 2013
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