Description

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.

Key Features

  • 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.

Readership

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.

Table of 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 – 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

Details

No. of pages:
262
Language:
English
Copyright:
© 2013
Published:
Imprint:
Academic Press
Print ISBN:
9780123978295
Electronic ISBN:
9780123978318

Reviews

"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