Hands-on Approach for the Conduct of Nonclinical Studies: A Manual for Anticipating and Avoiding Potential Problems focuses on practical approaches to real-life challenges faced during nonclinical studies, providing insights into the anticipation of potential problems and solutions to problems which may arise, thus saving time, money and resources. The book outlines Good Laboratory Practice in detail and includes regulatory guidelines, communication, stakeholder information and case studies. It is essential reading for study directors/technical coordinators, quality assurance personnel, all technical staff and project managers. In addition, it offers guidance for those new to the area, while also acting as a reference for senior researchers.
- Includes an introduction to Good Laboratory Practice (GLP) scenarios and related regulations
- Explains aspects of study directorship, including documentation, document review, implementation and execution of preclinical studies
- Provides a detailed account of the responsibilities of each stakeholder (technical, managerial, sponsor) within the study and how timely they need to act to seamlessly move a project
Table of Contents
1. The Stakeholders: The federal agencies aka the audience, the sponsors, and the management2. What is GLP?
3. Role and responsibilities of the sponsor, study director, and study coordinator
4. Study Director and Study Coordinator: Review of Test Article information and standardization of formulation procedure
5. Dose volume, analytical and bioanalytical method set-up for supporting nonclinical studies
6. Conduct of rodent and non-rodent MTD/DRF studies
7. Conduct of repeat dose toxicity studies in rodent and non-rodent species
8. Conduct of Genotoxicity studies (in vitro and in vivo)
9. Conduct of Safety Pharmacology studies
10. Conduct of DART program
11. Conduct of Carcinogenicity Studies
