{"product_id":"the-role-of-the-study-director-in-nonclinical-studies-isbn-9781118370391","title":"The Role of the Study Director in Nonclinical Studies","description":"\u003cp\u003eA 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:\u003c\/p\u003e \u003cul\u003e \u003cli\u003eProvides 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\u003c\/li\u003e \u003cli\u003eCovers regulatory and scientific concepts, including international testing and Good Laboratory Practice (GLP), compliance with guidelines, and animal models\u003c\/li\u003e \u003cli\u003eFeatures a concluding chapter that compiles case studies \/ lessons learned from those that have served as a Study Director for many years\u003c\/li\u003e \u003cli\u003eAddresses 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\u003c\/li\u003e \u003c\/ul\u003e \u003cp\u003eForeword ix\u003cbr\u003e\u003ci\u003eEdwin I. Goldenthal, PhD, ATS\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003ePreface xi\u003c\/p\u003e \u003cp\u003eContributors xiii\u003c\/p\u003e \u003cp\u003e1 Introduction to the Study Director 1\u003cbr\u003e\u003ci\u003eMary Ellen Cosenza, PhD, MS, DABT, RAC\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e2 Good Laboratory Practice Regulations: Roles of the Study Director, Management, and Quality Assurance Unit 7\u003cbr\u003e\u003ci\u003eBarbara Randolph, BS, MT (ASCP), MBA, RQAP (GLP)\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e3 International Guidelines and Regulations of Nonclinical Studies 27\u003cbr\u003e\u003ci\u003eBert Haenen, PhD, ERT, Linda Blous, Msc, and Anne Harman Chappelle, PhD, DABT\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e4 Facilities, Operations, Laboratory Animal Care, and Veterinary Services 43\u003cbr\u003e\u003ci\u003eSusan A. MacKenzie, VMD, PhD, DABT, Gregory W. Ruppert, BA, and David G. Serota, PhD, DABT\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e5 Regulatory Inspections 73\u003cbr\u003e\u003ci\u003eRussell James Eyre, PhD, DABT, Lijie Fu, PhD, MPH, Fellow ATS, and Eric Austin, PhD, DABT\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e6 Project Management and the Role of a Study Director 83\u003cbr\u003e\u003ci\u003eDebra Kirchner, PhD, DABT, Parthena Martin, PhD, DABT, and Brenda Frantz, BS\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e7 Managing Multi-site Studies: Roles of the Principal Investigator and the Study Director 95\u003cbr\u003e\u003ci\u003eSuzanne R.T. Wolford, PhD, DABT\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e8 Prestudy Preparation, the Protocol, Data Interpretation, and Reporting 107\u003cbr\u003e\u003ci\u003eCarol S. Auletta, DABT, MBA, RAC\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e9 Study Conduct 131\u003cbr\u003e\u003ci\u003eLisa Biegel, PhD, Heather Dale, PhD, and Mark Morse, PhD, DABT\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e10 \u003ci\u003eIn Vitro \u003c\/i\u003eToxicology Models 145\u003cbr\u003e\u003ci\u003eGertrude-Emilia Costin, PhD, MBA, and Hans Raabe, MS\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e11 Analytical Chemistry and Toxicology Formulations 171\u003cbr\u003e\u003ci\u003eEric S. Bodle, PhD, and Nutan Gangrade, PhD\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e12 Statistical Design and Analysis of Studies 191\u003cbr\u003e\u003ci\u003eJohn W. Green, PhD\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e13 Clinical Pathology 225\u003cbr\u003e\u003ci\u003eNiraj K. Tripathi, BVSc, MVSc, PhD, DACVP, Lila Ramaiah, BSc, DVM, PhD, DACVP, and Nancy E. Everds, DVM, DACVP\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e14 Effective Incorporation and Utilization of Biomarkers in Nonclinical Studies 245\u003cbr\u003e\u003ci\u003eMichael R. Bleavins, PhD, DABT\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e15 Pathology: Necropsy and Gross Pathology 259\u003cbr\u003e\u003ci\u003eCharles B. Spainhour, VMD, PhD, DABT\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e16 Histopathology in Toxicity Studies for Study Directors 275\u003cbr\u003e\u003ci\u003eKevin Keane, DVM, PhD, Fellow IATP\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e17 Toxicokinetics and Bioanalysis 297\u003cbr\u003e\u003ci\u003eAnthony L. Kiorpes, PhD, DVM, DABT\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e18 The Planning, Conduct, and Interpretation of Safety Pharmacology Studies: The Role of the Study Director in Safety Pharmacology Investigations 313\u003cbr\u003e\u003ci\u003eSimon Authier, DVM, MSc, MBA, PhD, DSP, Michael J. Curtis, PhD, FHEA, FBPharmacolS, DSP, and Michael K. Pugsley, PhD, FBPharmacolS, DSP\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e19 Genetic Toxicology Studies 333\u003cbr\u003e\u003ci\u003eRobert R. Young, MS, Mark Powley, PhD, Timothy E. Lawlor, MA, and Marilyn J. Aardema, PhD\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e20 Carcinogenicity Studies 355\u003cbr\u003e\u003ci\u003eReem Elbekai, BPharm, PhD, DABT, and Catherine M. Kelly, BS\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e21 Contemporary Practices in Core Developmental, Reproductive, and Juvenile Toxicity Assessments 371\u003cbr\u003e\u003ci\u003eAli Said Faqi, DVM, PhD, DABT, Fellow ATS\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e22 Immunotoxicology in Nonclinical Studies 393\u003cbr\u003e\u003ci\u003eFlorence G. Burleson, PhD, and Stefanie C.M. Burleson, PhD\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e23 Nonclinical Safety Assessment of Biotechnology-Derived Products: Considerations and Challenges 405\u003cbr\u003e\u003ci\u003eBarbara Mounho, PhD, DABT\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e24 Gene and Cell Therapy Products 427\u003cbr\u003e\u003ci\u003ePeter Working, PhD, DABT, Fellow ATS\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e25 Vaccines: Preventive and Therapeutic Product Studies 439\u003cbr\u003e\u003ci\u003eDeborah L. Novicki, PhD, DABT, Jayanthi J. Wolf, PhD, Lisa M. Plitnick, PhD, and Melanie Hartsough, PhD\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e26 Toxicology Studies Conducted for Pesticides and Commodity Chemicals 465\u003cbr\u003e\u003ci\u003eElliot Gordon, PhD, DABT, and Linda A. Malley, PhD, DABT\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e27 Medical Devices 485\u003cbr\u003e\u003ci\u003eGregory A. Kopia, PhD, and John F. Dooley, PhD\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e28 Lessons from the Front Lines 505\u003cbr\u003e\u003ci\u003eChristopher P. Chengelis, PhD, DABT, and C. Steven Godin, PhD, DABT\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003eIndex 519\u003c\/p\u003e  \u003cp\u003e\u003cb\u003eWilliam J. Brock\u003c\/b\u003e 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. \u003c\/p\u003e \u003cp\u003e\u003cb\u003eBarbara Mounho\u003c\/b\u003e is a Biopharmaceutical Practice Leader at ToxStrategies, Inc., a Diplomate of ABT and a Fellow of ATS.  Dr. Mounho has \u0026gt;15 years of experience in the nonclinical safety evaluation of therapeutic biological products.\u003c\/p\u003e \u003cp\u003e\u003cb\u003eLijie Fu\u003c\/b\u003e 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.\u003c\/p\u003e  \u003cp\u003e\u003cb\u003eInvaluable guidance to manage nonclinical safety studies\u003cbr\u003e \u003c\/b\u003e\u003cbr\u003e This book is a practical reference aiding Study Directors in the design, execution, and reporting of nonclinical studies. Managing the idiosyncrasies inherent in a nonclinical study represents a significant challenge that can only be learned from doing. The editors and authors provide such valuable lessons learned and case studies from their own extensive experience to guide readers. A single-source reference with a broad and holistic overview of nonclinical studies, this book: \u003c\/p\u003e \u003cul\u003e \u003cli\u003eProvides 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\u003c\/li\u003e \u003cli\u003eCovers regulatory and scientific concepts, including multi-site testing and Good Laboratory Practice (GLP) regulations, compliance with testing guidelines, and animal models\u003c\/li\u003e \u003cli\u003eFeatures a concluding chapter that compiles case studies \/ lessons learned from those that have served as a Study Director for many years\u003c\/li\u003e \u003cli\u003eAddresses 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\u003c\/li\u003e \u003c\/ul\u003e \u003cp\u003eIt begins with the basic concepts of regulatory definitions, international testing guidelines and Good Laboratory Practice (GLP) regulations, facility management, and regulatory inspections. The second part then 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 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.\u003c\/p\u003e \u003cp\u003eWith such comprehensive coverage across the spectrum of nonclinical testing, the book is applicable to several industries including pharmaceutical, safety science, biotechnology, and regulatory science.\u003c\/p\u003e","brand":"Wiley","offers":[{"title":"Default Title","offer_id":47990332686565,"sku":"NP9781118370391","price":138.95,"currency_code":"USD","in_stock":false}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/1842\/7735\/files\/9781118370391.jpg?v=1761787394","url":"https:\/\/k12savings.com\/es\/products\/the-role-of-the-study-director-in-nonclinical-studies-isbn-9781118370391","provider":"K12savings","version":"1.0","type":"link"}