eBook - ePub
The Role of the Study Director in Nonclinical Studies
Pharmaceuticals, Chemicals, Medical Devices, and Pesticides
- English
- ePUB (mobile friendly)
- Available on iOS & Android
eBook - ePub
The Role of the Study Director in Nonclinical Studies
Pharmaceuticals, Chemicals, Medical Devices, and Pesticides
About this book
A single-source reference with a broad and holistic overview of nonclinical studies, this book offers critical training material and describes regulations of nonclinical testing through guidelines, models, case studies, practical examples, and worldwide perspectives. The book:
- Provides a complete overview of nonclinical study organization, conduct, and reporting and describes the roles and responsibilities of a Study Director to manage an effective study
- Covers regulatory and scientific concepts, including international testing and Good Laboratory Practice (GLP), compliance with guidelines, and animal models
- Features a concluding chapter that compiles case studies / lessons learned from those that have served as a Study Director for many years
- Addresses the entire spectrum of nonclinical testing, making it applicable to those in the government, laboratories and those actively involved in in all sectors of industry
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Please note we cannot support devices running on iOS 13 and Android 7 or earlier. Learn more about using the app.
Yes, you can access The Role of the Study Director in Nonclinical Studies by William J. Brock in PDF and/or ePUB format, as well as other popular books in Ciencias físicas & Farmacología. We have over one million books available in our catalogue for you to explore.
Information
Table of contents
- Cover
- Table of Contents
- Title page
- Copyright page
- Foreword
- Preface
- Contributors
- 1: Introduction to the Study Director
- 2: Good Laboratory Practice Regulations: Roles of the Study Director, Management, and Quality Assurance Unit
- 3: International Guidelines and Regulations of Nonclinical Studies
- 4: Facilities, Operations, Laboratory Animal Care, and Veterinary Services
- 5: Regulatory Inspections
- 6: Project Management and the Role of a Study Director
- 7: Managing Multi-site Studies: Roles of the Principal Investigator and the Study Director
- 8: Prestudy Preparation, the Protocol, Data Interpretation, and Reporting
- 9: Study Conduct
- 10: In Vitro Toxicology Models
- 11: Analytical Chemistry and Toxicology Formulations
- 12: Statistical Design and Analysis of Studies
- 13: Clinical Pathology
- 14: Effective Incorporation and Utilization of Biomarkers in Nonclinical Studies
- 15: Pathology: Necropsy and Gross Pathology
- 16: Histopathology in Toxicity Studies for Study Directors
- 17: Toxicokinetics and Bioanalysis
- 18: The Planning, Conduct, and Interpretation of Safety Pharmacology Studies: The Role of the Study Director in Safety Pharmacology Investigations
- 19: Genetic Toxicology Studies
- 20: Carcinogenicity Studies
- 21: Contemporary Practices in Core Developmental, Reproductive, and Juvenile Toxicity Assessments
- 22: Immunotoxicology in Nonclinical Studies
- 23: Nonclinical Safety Assessment of Biotechnology-Derived Products: Considerations and Challenges
- 24: Gene and Cell Therapy Products
- 25: Vaccines: Preventive and Therapeutic Product Studies
- 26: Toxicology Studies Conducted for Pesticides and Commodity Chemicals
- 27: Medical Devices
- 28: Lessons from the Front Lines
- Supplemental Images
- Index
- End User License Agreement