Role of the Study Director in Nonclinical Studies

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 ixEdwin I. Goldenthal, PhD, ATSPreface xiContributors xiii1 Introduction to the Study Director 1Mary Ellen Cosenza, PhD, MS, DABT, RAC2 Good Laboratory Practice Regulations: Roles of the Study Director, Management, and Quality Assurance Unit 7Barbara Randolph, BS, MT (ASCP), MBA, RQAP (GLP)3 International Guidelines and Regulations of Nonclinical Studies 27Bert Haenen, PhD, ERT, Linda Blous, Msc, and Anne Harman Chappelle, PhD, DABT4 Facilities, Operations, Laboratory Animal Care, and Veterinary Services 43Susan A. MacKenzie, VMD, PhD, DABT, Gregory W. Ruppert, BA, and David G. Serota, PhD, DABT5 Regulatory Inspections 73Russell James Eyre, PhD, DABT, Lijie Fu, PhD, MPH, Fellow ATS, and Eric Austin, PhD, DABT6 Project Management and the Role of a Study Director 83Debra Kirchner, PhD, DABT, Parthena Martin, PhD, DABT, and Brenda Frantz, BS7 Managing Multi-site Studies: Roles of the Principal Investigator and the Study Director 95Suzanne R.T. Wolford, PhD, DABT8 Prestudy Preparation, the Protocol, Data Interpretation, and Reporting 107Carol S. Auletta, DABT, MBA, RAC9 Study Conduct 131Lisa Biegel, PhD, Heather Dale, PhD, and Mark Morse, PhD, DABT10 In Vitro Toxicology Models 145Gertrude-Emilia Costin, PhD, MBA, and Hans Raabe, MS11 Analytical Chemistry and Toxicology Formulations 171Eric S. Bodle, PhD, and Nutan Gangrade, PhD12 Statistical Design and Analysis of Studies 191John W. Green, PhD13 Clinical Pathology 225Niraj K. Tripathi, BVSc, MVSc, PhD, DACVP, Lila Ramaiah, BSc, DVM, PhD, DACVP, and Nancy E. Everds, DVM, DACVP14 Effective Incorporation and Utilization of Biomarkers in Nonclinical Studies 245Michael R. Bleavins, PhD, DABT15 Pathology: Necropsy and Gross Pathology 259Charles B. Spainhour, VMD, PhD, DABT16 Histopathology in Toxicity Studies for Study Directors 275Kevin Keane, DVM, PhD, Fellow IATP17 Toxicokinetics and Bioanalysis 297Anthony L. Kiorpes, PhD, DVM, DABT18 The Planning, Conduct, and Interpretation of Safety Pharmacology Studies: The Role of the Study Director in Safety Pharmacology Investigations 313Simon Authier, DVM, MSc, MBA, PhD, DSP, Michael J. Curtis, PhD, FHEA, FBPharmacolS, DSP, and Michael K. Pugsley, PhD, FBPharmacolS, DSP19 Genetic Toxicology Studies 333Robert R. Young, MS, Mark Powley, PhD, Timothy E. Lawlor, MA, and Marilyn J. Aardema, PhD20 Carcinogenicity Studies 355Reem Elbekai, BPharm, PhD, DABT, and Catherine M. Kelly, BS21 Contemporary Practices in Core Developmental, Reproductive, and Juvenile Toxicity Assessments 371Ali Said Faqi, DVM, PhD, DABT, Fellow ATS22 Immunotoxicology in Nonclinical Studies 393Florence G. Burleson, PhD, and Stefanie C.M. Burleson, PhD23 Nonclinical Safety Assessment of Biotechnology-Derived Products: Considerations and Challenges 405Barbara Mounho, PhD, DABT24 Gene and Cell Therapy Products 427Peter Working, PhD, DABT, Fellow ATS25 Vaccines: Preventive and Therapeutic Product Studies 439Deborah L. Novicki, PhD, DABT, Jayanthi J. Wolf, PhD, Lisa M. Plitnick, PhD, and Melanie Hartsough, PhD26 Toxicology Studies Conducted for Pesticides and Commodity Chemicals 465Elliot Gordon, PhD, DABT, and Linda A. Malley, PhD, DABT27 Medical Devices 485Gregory A. Kopia, PhD, and John F. Dooley, PhD28 Lessons from the Front Lines 505Christopher P. Chengelis, PhD, DABT, and C. Steven Godin, PhD, DABTIndex 519