The Role of the Study Director in Nonclinical Studies

William J. Brock 지음

Wiley 2014년 05월 02일 출간

작품소개

책소개

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 studyCovers regulatory and scientific concepts, including international testing and Good Laboratory Practice (GLP), compliance with guidelines, and animal modelsFeatures a concluding chapter that compiles case studies / lessons learned from those that have served as a Study Director for many yearsAddresses 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

목차

ForewordEdwin I. GoldenthalPrefaceContributorsChapter 1: Introduction to the Study DirectorMary Ellen CosenzaChapter 2: Good Laboratory Practice Regulations:& Roles of the Study Director, Management, and Quality Assurance UnitBarbara RandolphChapter 3: International Guidelines and Regulations of Non-clinical StudiesBert Haenen, Linda Blous, and Anne Harman ChappelleChapter 4: Facilities, Operations, Laboratory Animal Care and Veterinary ServicesSusan A. MacKenzie, Greg Ruppert, and David G. SerotaChapter 5: Regulatory InspectionsRussell James Eyre, Lijie Fu, and Eric AustinChapter 6: Project Management and the Role of a Study DirectorDebra Kirchner, Parthena Martin, and Brenda FrantzChapter 7: Managing Multi-Site Studies:& Role of Principal Investigators and the Study DirectorSuzanne R. T. WolfordChapter 8: Pre-Study Preparation, the Protocol, Data Interpretation and ReportingCarol S. AulettaChapter 9: Study ConductLisa Biegel, Heather Dale, and Mark MorseCahpter 10: In Vitro Toxicology ModelsGertrude-Emilia Costin and Hans RaabeChapter 11: Analytical Chemistry and Toxicology FormulationsEric S. Bodle and Nutan GangradeChapter 12: Statistical Design and Analysis of StudiesJohn W. GreenChapter 13: Clinical PathologyNiraj K. Tripathi, Lila Ramaiah, and Nancy E. EverdsChapter 14: Effective Incorporation and Utilization of Biomarkers in Nonclinical StudiesMichael R. BleavinsChapter 15: Pathology:& Necroscopy and Gross PathologyCharles B. SpainhourChapter 16: Histopathology in Toxicity Studies for Study DirectorsKevin KeaneChapter 17: Toxicokinetics and BioanalysisAnthony L. KiorpesChap

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저자(글) William J. Brock

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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.