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
Edited by:
William J. Brock (Brock Scientific Consulting)
Associate editor:
Barbara Mounho,
Lijie Fu
Imprint: John Wiley & Sons Inc
Country of Publication: United States
Dimensions:
Height: 287mm,
Width: 226mm,
Spine: 38mm
Weight: 1.538kg
ISBN: 9781118370391
ISBN 10: 1118370392
Pages: 560
Publication Date: 23 May 2014
Audience:
Professional and scholarly
,
Undergraduate
Format: Hardback
Publisher's Status: Active
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
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.
