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Nonclinical Study Contracting and Monitoring
A Practical Guide
- 1st Edition - December 31, 2012
- Editors: William F. Salminen, Joe M. Fowler, James Greenhaw
- Language: English
- Paperback ISBN:9 7 8 - 0 - 1 2 - 3 9 7 8 2 9 - 5
- eBook ISBN:9 7 8 - 0 - 1 2 - 3 9 7 8 3 1 - 8
Nonclinical Study Contracting and Monitoring: A Practical Guide offers a systematic and straightforward handbook for obtaining high quality preclinical Good Laboratory Practice… Read more
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Request a sales quoteNonclinical 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
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 – Records 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
Key Points
Confidentiality
Contracts
Maintaining Confidentiality During the Study
Business Ethics
Example of a Confidential Disclosure Agreement
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
Key Points
Test and Control Article Synthesis and Sourcing
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
Key Points
Test Article and Formulations
Acquiring 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 Arise
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
Key Points
Establishing the Working Relationship
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
Key Points
Finalizing the Report
Amending the Final Report
Study Close-Out
Conclusions
Index
- No. of pages: 262
- Language: English
- Edition: 1
- Published: December 31, 2012
- Imprint: Academic Press
- Paperback ISBN: 9780123978295
- eBook ISBN: 9780123978318
WS
William F. Salminen
Affiliations and expertise
PhD, DABT, PMP, PAREXEL International, Benton, ARJF
Joe M. Fowler
Affiliations and expertise
BS, RQAP-GLP, Director of the Quality Assurance Unit, National Center for Toxicological Research, FDA, Jefferson, ARJG
James Greenhaw
Affiliations and expertise
BS, LAT, Director of the Quality Assurance Unit, National Center for Toxicological Research, FDA, Jefferson, ARRead Nonclinical Study Contracting and Monitoring on ScienceDirect