Hands-on Approach for the Conduct of Nonclinical Studies - 1st Edition - ISBN: 9780128131008

Hands-on Approach for the Conduct of Nonclinical Studies

1st Edition

A Manual for Anticipating and Avoiding Potential Problems

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Editors: Deven Dandekar Pallavi Limaye
Paperback ISBN: 9780128131008
Imprint: Academic Press
Published Date: 1st June 2029
Page Count: 365
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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.

Key Features

  • 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


Study directors, toxicologists working in nonclinical drug development, toxicology professors and students, regulatory toxicologists, medical and veterinary scientists

Table of Contents

  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


No. of pages:
© Academic Press 2020
1st June 2029
Academic Press
Paperback ISBN:

About the Editor

Deven Dandekar

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

Affiliations and Expertise

Founder, Blue River Drug Development, LLC, USA

Pallavi Limaye

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.

Affiliations and Expertise

Principal Scientist, MRIGlobal, USA

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