LEADER 05586nam 2200697 450 001 9910132202203321 005 20200520144314.0 010 $a1-118-87392-0 010 $a1-118-87390-4 035 $a(CKB)3710000000107686 035 $a(EBL)1684794 035 $a(SSID)ssj0001196118 035 $a(PQKBManifestationID)11763147 035 $a(PQKBTitleCode)TC0001196118 035 $a(PQKBWorkID)11165259 035 $a(PQKB)10244062 035 $a(OCoLC)865452422 035 $a(MiAaPQ)EBC1684794 035 $a(Au-PeEL)EBL1684794 035 $a(CaPaEBR)ebr10868208 035 $a(CaONFJC)MIL604417 035 $a(PPN)224780352 035 $a(EXLCZ)993710000000107686 100 $a20140516h20142014 uy 0 101 0 $aeng 135 $aur|n|---||||| 181 $ctxt 182 $cc 183 $acr 200 04$aThe role of the study director in nonclinical studies $epharmaceuticals, chemicals, medical devices, and pesticides /$fedited by William J. Brock ; associate editors Barbara J. Mounho, Lijie Fu 210 1$aHoboken, New Jersey :$cJohn Wiley & Sons,$d2014. 210 4$dİ2014 215 $a1 online resource (570 p.) 300 $aIncludes index. 311 $a1-118-37039-2 327 $aCover; Title page; Copyright page; Contents; Foreword; Preface; Contributors; 1: Introduction to the Study Director; 1.1 Definition of Study Director; 1.2 Regulatory History on the Scope of the Role; 1.2.1 FDA 1976 Proposed Rule (41 FR 1976); 1.2.2 FDA 1978 Final Rule (43 FR 1978); 1.2.3 OECD Consensus Document 1999 (OECD, 1999); 1.3 Guidance on Study Director Qualifications and Training; 1.3.1 OECD on Qualifications of the Study Director; 1.3.2 OECD on Training of Study Directors; 1.4 Study Director Training Courses; 1.5 Summary; References 327 $a2: Good Laboratory Practice Regulations: Roles of the Study Director, Management, and Quality Assurance Unit2.1 Introduction and Objectives; 2.2 Regulation Attempts Prior to 1930; 2.3 Critical Events Leading to Regulations; 2.4 Nonclinical Regulation; 2.5 The Purpose of GLP Regulation; 2.6 Industry Benefits of the GLP; 2.7 Requirements of the GLP; 2.8 The Role of Management; 2.9 The Role of the Study Director; 2.10 The Role of the Quality Assurance Unit; 2.11 A Brief Word about the Multi-site GLP Study; 2.12 GLP Interpretation Guidance; 2.13 FDA Concerns and the Future 327 $a2.14 Comparing GLP Standards: FDA, EPA, and OECD2.15 Summary; References; 3: International Guidelines and Regulations of Nonclinical Studies; 3.1 General Introduction; 3.2 Scope; 3.3 Legislation, Guidelines, and Regulations; 3.3.1 General; 3.3.2 Globally Acting Organizations; 3.3.3 Region-Specific Regulations; 3.4 Studies; 3.4.1 Screening Information Dataset (SIDS) Dossier; 3.4.2 REACH Data Requirements (Tiers 1-3); 3.4.3 A Discussion on Weight of Evidence and Klimisch Codes; 3.5 Summary; References; 4: Facilities, Operations, Laboratory Animal Care, and Veterinary Services; 4.1 Introduction 327 $a4.1.1 Regulatory Oversight and Accreditation Requirements4.1.2 Interaction between GLP and Animal Welfare Regulations; 4.1.3 Control of Study Variables; 4.2 Facilities; 4.2.1 Organization, Personnel, and Management; 4.2.2 Job Descriptions, Training Records, Curriculum Vitae (CV), and Organizational Charts; 4.2.3 Test Facility Design, Construction, and Maintenance; 4.2.4 Formulation Preparation Facilities; 4.2.5 Test and Control Articles; 4.2.6 Specialty Laboratories; 4.2.7 Quality Assurance Unit (QAU): Role and Responsibilities; 4.3 Laboratory Operations 327 $a4.3.1 Standard Operating Procedures (SOPs)4.3.2 Reagents and Solutions; 4.3.3 Laboratory Systems and Electronic Records; 4.3.4 Laboratory Instrumentation/Equipment; 4.3.5 Emergency Disaster Plan; 4.4 Laboratory Animal Care and Veterinary Services; 4.4.1 Regulatory Oversight and Accreditation; 4.4.2 Animal Care Facilities; 4.4.3 Animal Health and Veterinary Services Program; 4.4.4 Health Maintenance Program; 4.4.5 Veterinary Services Program; 4.4.6 Veterinary and Animal Care Procedures; 4.5 Other Species; References; 5: Regulatory Inspections; 5.1 Introduction 327 $a5.2 Purpose and Types of Regulatory Inspections 330 $aA 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), complian 606 $aMedical laboratories$xQuality control 606 $aBiological laboratories$xQuality control 606 $aHealth occupations schools 606 $aAllied health personnel$xIn-service training 615 0$aMedical laboratories$xQuality control. 615 0$aBiological laboratories$xQuality control. 615 0$aHealth occupations schools. 615 0$aAllied health personnel$xIn-service training. 676 $a616.07/5 702 $aBrock$b William J. 702 $aMounho$b Barbara J. 702 $aFu$b Lijie 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910132202203321 996 $aThe role of the study director in nonclinical studies$91980662 997 $aUNINA