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Hands-on Approach for the Conduct of Nonclinical Studies

  • ID: 4519368
  • Book
  • June 2020
  • 365 Pages
  • Elsevier Science and Technology

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
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1. The Stakeholders: The federal agencies aka the audience, the sponsors, and the management
2. 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
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Dandekar, Deven
Dr. Dandekar has over 15 years of experience working in academia, agrochemical and pharmaceutical research and development. He has been involved in the completion of multiple successful IND enabling programs supporting clinical development and leading to strong regulatory submissions of New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for various biotech/pharmaceutical companies (Sponsor's). He earned his zoology doctorate from the Maharaja Sayajirao University of Baroda, India. Dr. Dandekar has given expert lectures at a variety of institutions and published multiple scholarly articles
Limaye, Pallavi B.
Dr. Limaye has written over a dozen papers and book chapters and has worked as a postdoctoral fellow at the University of Pittsburgh School of Medicine and the University of Kansas Medical Center. She earned her PhD from University of Louisiana at Monroe in Toxicology.
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