The Role of the Study Director in Nonclinical Studies

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 INDICE: Foreword Edwin I. Goldenthal Preface Contributors Chapter 1: Introduction to the Study Director Mary Ellen Cosenza Chapter 2: Good Laboratory Practice Regulations:  Roles of the Study Director, Management, and Quality Assurance Unit Barbara Randolph Chapter 3: International Guidelines and Regulations of Non–clinical Studies Bert Haenen, Linda Blous, and Anne Harman Chappelle Chapter 4: Facilities, Operations, Laboratory Animal Care and Veterinary Services Susan A. MacKenzie, Greg Ruppert, and David G. Serota Chapter 5: Regulatory Inspections Russell James Eyre, Lijie Fu, and Eric Austin Chapter 6: Project Management and the Role of a Study Director Debra Kirchner, Parthena Martin, and Brenda Frantz Chapter 7: Managing Multi–Site Studies:  Role of Principal Investigators and the Study Director Suzanne R. T. Wolford Chapter 8: Pre–Study Preparation, the Protocol, Data Interpretation and Reporting Carol S. Auletta Chapter 9: Study Conduct Lisa Biegel, Heather Dale, and Mark Morse Cahpter 10: In Vitro Toxicology Models Gertrude–Emilia Costin and Hans Raabe Chapter 11: Analytical Chemistry and Toxicology Formulations Eric S. Bodle and Nutan Gangrade Chapter 12: Statistical Design and Analysis of Studies John W. Green Chapter 13: Clinical Pathology Niraj K. Tripathi, Lila Ramaiah, and Nancy E. Everds Chapter 14: Effective Incorporation and Utilization of Biomarkers in Nonclinical Studies Michael R. Bleavins Chapter 15: Pathology:  Necroscopy and Gross Pathology Charles B. Spainhour Chapter 16: Histopathology in Toxicity Studies for Study Directors Kevin Keane Chapter 17: Toxicokinetics and Bioanalysis Anthony L. Kiorpes Chapter 18: The Planning, Conduct and Interpretation of Safety Pharmacology Studies: The Role of the Study Director in Safety Pharmacology Investigations Simon Authier, Michael. J. Curtis, and Michael K. Pugsley Chapter 19: Genetic Toxicology Studies Robert R. Young, Mark Powley, Timothy E. Lawlor, and Marilyn J. Aardema Chapter 20: Carcinogenicity Studies Reem Elbekai and Catherine M. Kelly Chapter 21: Contemporary Practices in Core Developmental, Reproductive and Juvenile Toxicity Assessments Ali Said Faqi Chapter 22: Immunotoxicology in Nonclinical Studies Florence G. Burleson Chapter 23: Nonclinical Safety Assessment of Biotechnology–Derived Products: Considerations and Challenges Barbara J. Mounho–Zamora Chapter 24: Gene and Cell Therapy Products Peter Working Chapter 25: Vaccines: Preventive and Therapeutic Product Studies Deborah L. Novicki, Jayanthi J. Wolf, Lisa M. Plitnick, and Melanie Hartsough Chapter 26: Toxicology Studies Conducted for Pesticides and Commodity Chemicals Elliot Gordon and Linda A. Malley Chapter 27: Medical Devices Gregory A. Kopia and John F. Dooley Chapter 28: Lessons from the Front Lines C.P. Chengelis and C.S. Godin Index

• ISBN: 978-1-118-37039-1
• Editorial: Wiley–Blackwell
• Encuadernacion: Cartoné
• Páginas: 464
• Fecha Publicación: 29/08/2014
• Nº Volúmenes: 1
• Idioma: Inglés