The Role of the Study Director in Nonclinical Studies

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