Hands On Approach for the Conduct of Nonclinical Studies

  • Author : Deven Dandekar
  • Publsiher : Academic Press
  • Release : 01 March 2019
  • ISBN : 0128131004
  • Page : 365 pages
  • Rating : 4/5 from 21 voters

Download or read online book entitled Hands On Approach for the Conduct of Nonclinical Studies written by Deven Dandekar and published by Academic Press. This book was released on 01 March 2019 with total page 365 pages. Available in PDF, EPUB and Kindle. Get best books that you want by click Get Book Button and Read as many books as you like. Book Excerpt : 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, 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 the 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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