The Role of the Study Director in Nonclinical Studies: Pharmaceuticals, Chemicals, Medical Devices, and Pesticides

This book is a practical reference aiding Study Directors to approach a study and pull data together for interpretation. Managing the idiosyncrasies inherent in a nonclinical study represents a significant challenge that can only be learned from doing, and the editors and authors provide such valuable lessons learned and case studies from their own extensive experience to guide readers. The book covers the spectrum of nonclinical testing, making it applicable to several industries including pharmaceutical, safety science, biotechnology, and regulatory. The book begins with the basic concepts including the regulatory definitions, international testing guidelines and Good Laboratory Practice (GLP) regulations, facility management, and regulatory inspections. The second part of the book deals with the conduct of a nonclinical study, critical to a successful outcome, and one of the more challenging tasks for a Study Director: developing a protocol. The third section of the book describes specialized studies and the final chapter compiles the case studies and lessons learned from those that have been active participants in nonclinical studies for many years.

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

William J. Brock is the Principal of Brock Scientific Consulting, a Diplomate of ABT and a Fellow of ATS.  He has experience with conducting nonclinical studies including genotoxicity, safety pharmacology, developmental and reproductive toxicology, carcinogenicity studies, etc.  Barbara Mounho is a Biopharmaceutical Practice Leader at ToxStrategies, Inc., a Diplomate of ABT and a Fellow of ATS.  Dr. Mounho has >15 years of experience in the nonclinical safety evaluation of therapeutic biological products. Lijie Fu is the Senior Director and Regulatory Advisor at SNBL. He is a Fellow of ATS with over 30 years′ experience in toxicology, holding positions in non–clinical CROs in the US and China.  Dr. Fu was retained by WHO as an expert to on Safety Evaluation and GLP Regulations.