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

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

William J. Brock is the Principal of Brock Scientific Consulting, a Diplomate of ABT and a Fellow of ATS.  Dr. Brock has over 30 years of 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.

Foreword ix
Edwin I. Goldenthal, PhD, ATS

Preface xi

Contributors xiii

1 Introduction to the Study Director 1
Mary Ellen Cosenza, PhD, MS, DABT, RAC

2 Good Laboratory Practice Regulations: Roles of the Study Director, Management, and Quality Assurance Unit 7
Barbara Randolph, BS, MT (ASCP), MBA, RQAP (GLP)

3 International Guidelines and Regulations of Nonclinical Studies 27
Bert Haenen, PhD, ERT, Linda Blous, Msc, and Anne Harman Chappelle, PhD, DABT

4 Facilities, Operations, Laboratory Animal Care, and Veterinary Services 43
Susan A. MacKenzie, VMD, PhD, DABT, Gregory W. Ruppert, BA, and David G. Serota, PhD, DABT

5 Regulatory Inspections 73
Russell James Eyre, PhD, DABT, Lijie Fu, PhD, MPH, Fellow ATS, and Eric Austin, PhD, DABT

6 Project Management and the Role of a Study Director 83
Debra Kirchner, PhD, DABT, Parthena Martin, PhD, DABT, and Brenda Frantz, BS

7 Managing Multi-site Studies: Roles of the Principal Investigator and the Study Director 95
Suzanne R.T. Wolford, PhD, DABT

8 Prestudy Preparation, the Protocol, Data Interpretation, and Reporting 107
Carol S. Auletta, DABT, MBA, RAC

9 Study Conduct 131
Lisa Biegel, PhD, Heather Dale, PhD, and Mark Morse, PhD, DABT

10 In Vitro Toxicology Models 145
Gertrude-Emilia Costin, PhD, MBA, and Hans Raabe, MS

11 Analytical Chemistry and Toxicology Formulations 171
Eric S. Bodle, PhD, and Nutan Gangrade, PhD

12 Statistical Design and Analysis of Studies 191
John W. Green, PhD

13 Clinical Pathology 225
Niraj K. Tripathi, BVSc, MVSc, PhD, DACVP, Lila Ramaiah, BSc, DVM, PhD, DACVP, and Nancy E. Everds, DVM, DACVP

14 Effective Incorporation and Utilization of Biomarkers in Nonclinical Studies 245
Michael R. Bleavins, PhD, DABT

15 Pathology: Necropsy and Gross Pathology 259
Charles B. Spainhour, VMD, PhD, DABT

16 Histopathology in Toxicity Studies for Study Directors 275
Kevin Keane, DVM, PhD, Fellow IATP

17 Toxicokinetics and Bioanalysis 297
Anthony L. Kiorpes, PhD, DVM, DABT

18 The Planning, Conduct, and Interpretation of Safety Pharmacology Studies: The Role of the Study Director in Safety Pharmacology Investigations 313
Simon Authier, DVM, MSc, MBA, PhD, DSP, Michael J. Curtis, PhD, FHEA, FBPharmacolS, DSP, and Michael K. Pugsley, PhD, FBPharmacolS, DSP

19 Genetic Toxicology Studies 333
Robert R. Young, MS, Mark Powley, PhD, Timothy E. Lawlor, MA, and Marilyn J. Aardema, PhD

20 Carcinogenicity Studies 355
Reem Elbekai, BPharm, PhD, DABT, and Catherine M. Kelly, BS

21 Contemporary Practices in Core Developmental, Reproductive, and Juvenile Toxicity Assessments 371
Ali Said Faqi, DVM, PhD, DABT, Fellow ATS

22 Immunotoxicology in Nonclinical Studies 393
Florence G. Burleson, PhD, and Stefanie C.M. Burleson, PhD

23 Nonclinical Safety Assessment of Biotechnology-Derived Products: Considerations and Challenges 405
Barbara Mounho, PhD, DABT

24 Gene and Cell Therapy Products 427
Peter Working, PhD, DABT, Fellow ATS

25 Vaccines: Preventive and Therapeutic Product Studies 439
Deborah L. Novicki, PhD, DABT, Jayanthi J. Wolf, PhD, Lisa M. Plitnick, PhD, and Melanie Hartsough, PhD

26 Toxicology Studies Conducted for Pesticides and Commodity Chemicals 465
Elliot Gordon, PhD, DABT, and Linda A. Malley, PhD, DABT

27 Medical Devices 485
Gregory A. Kopia, PhD, and John F. Dooley, PhD

28 Lessons from the Front Lines 505
Christopher P. Chengelis, PhD, DABT, and C. Steven Godin, PhD, DABT

Index 519

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