The first chapter is drug safety evaluation and GLP. 1
Section 1 History of GLP ... 1
Section II GLP Directory ... IV
Section III Implementation Steps of GLP ... 19
Chapter II How to Write Standard Operating Procedures? 25
Section 1 Introduction ... 25
The second quarter programming standard operating procedures ... 28
Section III General Format of Standard Operating Procedures ... 30
Section IV Types of Standard Operating Procedures ... 30
Section 5 Management of Standard Operating Procedures ... 32
Section 6 sop Example ... 32
Chapter III Non-clinical Safety Evaluation of Drugs ... 42
Section I Overview ... 42
Section 2 Legal Basis for Drug Safety Evaluation ... 44
In the third quarter, drug safety evaluation normative documents (mandatory documents) 47 pages
Section IV Guiding Principles for Drug Safety Evaluation (Suggestive Document) 48
Section 5 Requirements for Experimental Animals ... 50
Section 6 Requirements for Test Articles ... 52
Section VII Basic Contents of Drug Safety Evaluation ... 52
Section VIII Items Required for Toxicological Safety Test under GLP Conditions ... 57
Chapter IV International Coordination Meeting on Technical Requirements for the Registration of Medicines for Human Use ...
Section 1 Formulation and Implementation Steps of Intangible Cultural Heritage Guidelines ... 60
Section 2 Guiding Principles for Single Dose Toxicity Test (ICH S4)...6 1
Section III Repeated Toxicity Test (ICH S4, M3)...6 1
Section IV Guiding Principles of Drug Reproductive Toxicity Test (ICH S5A and ICH S5B)...63
Section 5 genotoxicity test (ICH S2A)...64
Section VI Guiding Principles of Carcinogenesis Research ... 66
Section VII Pre-clinical Safety Evaluation of ICH Biotechnology Derived Drugs (ICH S6) ...
Section 8 added security issues and guiding principles ... 69
Section IX ICH S2(R 1) Guiding principles for genotoxicity experiment and data evaluation of human drugs ...
The second article experimental animals ... 79
Chapter V Experimental Animals and Animal Experiments ... 79
Section I Introduction 79
Section 2 Experimental Animals and Toxicological Safety Assessment ... 98
Section III Factors Affecting Animal Experiments ... 98
Section 4 Animal Feeding ... 105
Chapter VI Responsibilities of Animal Management Institutions and Personnel ... 1 14
Section 1 Responsibilities and Qualifications of Animal Managers and Users ... 1 14
Section 2 Animal Feeding Facilities and Managers ... 1 14
Section III Education and Training Plan for Animal Researchers (USA) ... 1 18
Section IV Education Plan for Animal Feeding Management Technicians of American Laboratory Animal Association ... 1 19.
Section 5 Education and training of animal workers recommended by the European Federation of Experimental Animal Associations ... 126
Section VI Training under GLP System ... 142
Chapter VII Animal Management and Utilization Committee Organization and Its Responsibilities ... 147
Section 1 Animal Management and Utilization Committee ... 147
Section 2 Examples of IACUC Animal Research Project Application and Evaluation ... 150
Section III Handling Procedures for Improper Handling of Animals and Non-compliance with Animal Management and Use Requirements ... 163
Section 4 IACUC related standard operating procedures. 165
Chapter VIII Occupational Health and Personal Safety ... 169
Section 1 General requirements of national laws and regulations on laboratory biosafety ... 169
Section 2 Occupational Health and Safety and Staff Training ... 170
Section 3 Animal Experiment of Dangerous Drugs ... 176
Section IV Specific Standard Operating Procedures ... 178
Chapter IX Veterinary Management-Health Monitoring and Diseases ... 189
Section 1 Veterinary and Animal Veterinary Care and Management ... 189
Section 2 Animal Veterinary Management-Purchase, Transportation, Receiving and Quarantine of Laboratory Animals ... 190
Section 3 Animal Health Monitoring ... 199
Section 4 Animal Veterinary Management-Anesthesia, Analgesia, Surgery and Euthanasia ... 2 10
Section 5 Strategies for Long-term Fixation of Animals ... 2 18
Section 6 Blood Collection ... 2 19
Section 7 Drug Administration and Narcotics Control (Controlled Drugs) ... 22 1
Section 8 Diseases of People and Livestock and Their Prevention ...
Chapter X Management and Monitoring of Laboratory Animal Feeding Environment ... 225
Section 1 Management and Monitoring of Laboratory Animal Feeding Environment ... 225
Section 2 Some Special Requirements for Animal Feeding Management ... 250
Section III Feeding, Management and Use Procedures of Rodents ... 255
Chapter II XI Experiments in Mice and Rats Based on GLP Principle ... 258
Section 1 Veterinary Care and Management of Mice and Rats ...
Section II Rodent Feeding Management ... 275
Section III Management Methods of Rodents ... 28 1
Section IV Blood Collection, Urine Collection, Feces and Bone Marrow Samples ... 287
Section V Inspection of Indicators ... 292
Section VI Autopsy Procedure for Rats/Mice ... 295
Chapter XII Animal Experiment of Radioactive Samples ... 300
Section 1 Overview ... 300
Section 2 Receiving, Storage and Waste Disposal of Radioactive Substances ... 302
Section III Standard Operating Procedures for Animal Experiments of Radioactive Substances ... 307
Chapter XIII Biological Agents and Infectious Animal Experiments ...
Section 1 Provisions on the Administration of Animal Tests of Biological Agents and Infectious Agents ...
Section 2 Specification for the Use of Animal Infection Experiments ... 325
Section 3 Application of Animal Experiment of Biomaterials ... 33 1
Chapter XIV Animal Experiment of Harmful Substances (Toxic, Carcinogenic, Teratogenic and Mutagenic Substances) ... 4 1
Section 1 General Requirements for Laboratory Biosafety ... 34 1
Section 2 Safety Issues in Safety Assessment of Hazardous Chemicals ... 34 1
Chapter 15 Non-human primate experiments conforming to GLP principles ... 345
The first section monkey feeding management ... 345
In the second quarter, primate feeding management procedures ... 369
Section III Preparation Procedures for Nonhuman Primate Laboratories ... 370
Section IV Acceptance and Quarantine of Nonhuman Primates ... 37 1
Section 5 Breeding Environment of Primates ... 377
Section VI Management Procedures for Primate Feeding ... 383
Section 7 Operation and Observation Procedures of Primates ... 385
Section VIII Administration Procedures for Non-human Primates ... 396
Section 9 Collection of primate biological samples ... 40 1
Section 10 Procedures for handling dead primates ... 403
Section 11 Occupational Hazards and Protection Procedures of Non-human Primates ...
Chapter 16 Toxicity test on rabbits according to the principle of GLP ... 408
Section 1 Veterinary Management of Rabbits-Receiving and Quarantine ... 408
Section II Rabbit Feeding Management Procedures ... 4 14
Section III Operating Procedures of Rabbits ... 420
Section IV Observation Procedure of Clinical Signs in Rabbits ...
Section 5 Procedures for Collecting Biological Samples of Rabbits ... 427
Section VI Main Records of Rabbit Feeding Management ... 430
Chapter 17 Toxicity Test of Dogs Conforming to GLP Principle ... 33 1
Part 1: Overview of dog experiments under GLP conditions ... 33 1
Section 2 Standard Operating Procedures for Dog Ordering, Receiving and Quarantine ...
Section 3 Dog Raising and Management ... 444
Section iv detection and observation of clinical indexes of dogs ... 40014.40000.00000000005
Section 5 Dog Raising Management Procedures ... 463
Section VI Collection Procedures of Dog Biological Samples ... 470
Chapter 18 Toxicological tests were conducted on guinea pigs and hamsters according to the principle of GLP ............
Section 1 Veterinary Management of Guinea Pigs-Purchase, Receiving and Quarantine Procedures ...
Section 2 Feeding Management and Administration Procedure of Guinea Pigs ... 474
Chapter XIX Glossary of Terms Used in Toxicological Safety Assessment ... 478
Section 1 Standardized definition and observation methods of animal signs ...
Section II Observation Indexes and Application Terms of Mammalian Dysplasia ... 496
Section 3 Glossary of Terms Related to Carcinogen Detection ... 504
Section IV Compilation of Terms Related to Genotoxicity Test ... 508
Section 5 Glossary of Terms Related to Ophthalmology ... 508
Part III Application of Pathology in Safety Evaluation ... 5 12
Chapter 20 Introduction of Toxicology and Pathology Operating Procedures ... 5 12
Section 1 Overview of Toxicology and Pathology ... 5 12
Section II Pathological Raw Data ... 5 18
Section III Histopathological Assessment ... 520
Section IV Evaluation of Pathological Image Data ... 526
Section 5 Quality Evaluation of Pathology Database and Toxicology Genomics Research ...
Chapter 21 Toxicological Pathology Technology ... 534
Section 1 Application of Modern Imaging Technology in Toxicological Pathology ...
New application of digital microscopic imaging technology in toxic pathology ...
Section III Qualitative and Quantitative Analysis of Non-neoplastic Lesions ...
Section IV Immunohistochemical Techniques ... 547
Section 5 In situ hybridization technology ... 55 1
Section 6. In situ PCR technology and its application in pathology ...
Section 7 Application of Morphometry and Image Analyzer in Toxicological Pathology ...
Section 8: laser scanning * * * focusing microscope and its application in toxicology and pathology .......58000.00000000005
Section 9 Common Methods of Apoptosis Detection and Their Advantages and Disadvantages ... 577
Chapter XXII Basic Operation of Toxicology and Pathology ...
The first section pathological tissue processing flow ... 584
Section 2 Animal Autopsy Procedure ... 587
Section III Preliminary Anatomy and External Examination Procedures of Various Animals ... 59 1
Section IV Pathological Examination Procedure of Inhalation Toxicity Test in Rats ...
Section 5 Wet wipes pruning ... 609
Section VI Operating Specifications for Taking Materials and Cutting Organs of STP Rats and Mice ... 6 12
Section 7 Organization Fixation, Dehydration and Burying Procedures ... 622
Section 8 Tissue Embedding ... 624
Section 9 Trimming and Slicing of Tissue Wax ... 627
Section 10 Staining and Fixing of Slices ... 628
Section 1 1 Quality Control and Labeling of Slices ... 629
Section 12 continuous slicing ... 630
Section 13 Secondary Embedding Program ... 630
Section 14 decalcification procedure of bone tissue ... 63 1
Section 15 Special dyeing technical procedures ... 632
Section 16 preparation of blood smear during autopsy ...
Section 17 Fast Fixing of Formaldehyde Vapor ... 633
Section 18 Pathological section reading program ... 633
Section 19 Evaluation criteria for respiratory histopathology of rodents ...
Section 20 Histopathology Delivery Form ... 635
Section 2 1 Histological Records of Individual Animals in Histopathology Laboratory ... 636
Section 22 Archiving of pathological data ... 636
Section 23 Use and maintenance of cryoslicer ... 642
Chapter 23 Basic operation of new techniques in toxicology and pathology ...
Section 1 Standard Operating Procedures for Sample Preparation of Electron Microscope ...
Section II Basic Operation of Immunohistochemistry ... 649
Section 3 Basic operation of in-situ hybridization ... 666
The fourth section in situ PCR operating procedures ... 688
Section 5 Basic operation of morphological technique to detect apoptosis ...
Chapter XXIV Overview of Clinicopathological Examination ... 697
Section 1 Requirements for Guiding Principles of International Toxicity Test Standards-Clinical and Pathological Detection Indicators ... 697
In the second quarter, the requirements of the guiding principles of toxicity test standards-the interval of clinical and pathological examination ... 698
The significance of clinical and pathological changes in the third quarter ...
The fourth quarter hematology test problems ... 702
Section 5 Blood Biochemical Examination ... 706
Section VI Problems Related to Urine Analysis ... 7 1 1
Section 7 Data Interpretation ... 7 13
Section 8 Sampling and Marking Procedures ... 7 19
Section 9 Genetic Analysis Mouse Tissue Collection ... 720
Section 10 Inspection of Clinical Laboratory Samples ... 72 1
Chapter 25 Standard Operating Procedures for Clinicopathological Detection ... 722
Section 1 Blood samples for hematological examination ... 722
Section 2 Clinical Chemistry ... 729
Chapter 26 Evaluation of Bone Marrow Cells ... 740
The first section bone marrow hematopoiesis and blood toxicology ... 740
Section II Standard Operating Procedures for Bone Marrow Examination of Rats and Mice ... 740
Section III Dog Bone Marrow Examination Procedure ...
Article 4 Genetic toxicology tests shall be conducted in accordance with the principle of GLP ...
Chapter 27 Overview of Genetic Toxicology Tests ... 749
The first section genetic toxicological evaluation ... 749
Section 2 Principles of Genetic Toxicology Test ... 754
The third section introduces the application of OECD GLP principle in in vitro experiments ...
Section IV Biological Safety and Protection of Genetic Toxicology Test ... 760
Chapter 28 General standard operating procedures for in vitro genotoxicity test ...
Section one. Operation and safety procedures of mutagenicity test in vitro ...
Section 2 Handling, Weighing and Disposal of Toxicological Test Samples in Vitro ... 764
Section III Storage, Operation and Management of Radioactive Samples in Toxicological Tests in Vitro
Section 4 Storage, Operation and Treatment of Microbial Materials ...
Section 5 Storage, Operation and Treatment of Tissue Culture Materials ...
Section 6 Use of Biosafety Cabinet ... 769
Section 7 Use of Autoclave and Sterilization Pot ... 770
Section 8 Calibration and Use of Colony Counter ... 77 1
Section 9 Recording and archiving of in vitro toxicological test results ... 77 1
Section 10 Sterilization of culture medium and glassware ... 772
Preparation of liver homogenate and S9 mixture by slicing XI ... 773
Section XII Quality Control Test of Liver S9 Preparation ... 777
Section 13 preparation, quality control and storage of cell culture medium for tissue culture ...
Chapter 29 Standard Operating Procedures Related to Ames Test ...
Section 1 Ames Standard Test Procedure ...
Section 2 Maintenance and Preservation of Experimental Strains ... 796
The third section Ames test explains the identification procedure of the strain ...
The fourth quarter Ames test quality control ... 802
Section 5 Ames test colony count and its evaluation ...
Section VI Preparation and Storage of Ames Test Reagents ... 8 10
Section VII Ames Test Plan, Report and QAU Review ... 828
Chapter 30 Mutation test with Escherichia coli as indicator ... 840
Section 1 Introduction ... 840
Section 2 TRP reversion mutation test of Escherichia coli ... 840
Section 3 DNA repair test of Escherichia coli ... 844
Section IV Preparation, Quality Control and Preservation of Culture Solution for Tryptophan Recovery Test of Escherichia coli ...
Section 5 Preparation, Quality Control and Preservation of E.coli DNA Repair Test Medium ...
Chapter 31 Yeast Gene Mutation Test ... 85 1
Section 1 Recombination Test and Result Analysis of Yeast D5 ... 85 1
Section 2 Quality Control, Maintenance and Storage of Yeast D5 ...
Section III Mitotic Recombination Test of Yeast D5 ... 854
Section 4: preparation, quality control and preservation of culture medium in yeast D5 recombination test .50000.000000000105
Chapter 32 Micronucleus Test Technology in Accordance with GLP Principle ...
Section 1 Micronucleus Test Procedure of Rodent Bone Marrow Cells ...
Section 2 Cell micronucleus test in vitro ... 859
Section III Standard Operating Procedures for Micronucleus Test ... 864
Section IV Micronucleus Test Scheme, Report and Audit ...
Chapter 33 Chromosome aberration test conforms to GLP principle. ...
The first section experimental method of chromosome aberration in vivo ... 875
Section 2 Procedures for chromosome aberration test in vitro ... 878
Section III General Procedures of Chromosome Aberration Tests in vitro and in vivo ...
Section IV Application of Cytogenetics in Vitro Metabolic Activation System ... 908
Section V Drafting and Review of Chromosome Aberration Test Scheme and Report ... 9 12
Chapter 34 detection of DNA damage and repair —— comet test and UDS test ......58000.00000000065
Section 1 Inspection of DNA Damage-Comet Test Procedure ... 924
Section 2 Detection of DNA repair in rat hepatocytes by out-of-procedure DNA synthesis (UDS) test ...
Section 3 DNA repair test of human cells ... 930
Section 4 DNA repair test with [H]- deoxyuridine analysis ...
Section 5 Autoradiography DNA Repair Experiment ... 933
Section 6 standard operating procedures. 934 is related to user definition.
Section 7 Preparation of UDS Experimental Reagent ... 955
Chapter 35 Standard Operating Procedures for Gene Mutation Test of Mammalian Cells ... 97 1
Part 1: Overview of mammalian cell mutation test ... 97 1
Section II Detection of Forward Mutation of TK Gene in L5 178Y Mouse Lymphoma ...
Section III Drafting of L5 178Y/TK Mouse Lymphoma Detection Scheme ... 100 1
Section IV Mutagenicity Test of V79 and V79 Derived HPRT-/GPT+ G 12 Cells ... 1004
Section 5 CHO HGPRT Forward Mutation Test Scheme ... 1007
Chapter 36 Cell Transformation Test Methods ... 10 13
The first part is the experiment of malignant transformation of Syrian hamster embryonic cells in vitro. ...
Cell transformation test of BHK (young hamster kidney cells) ...10/6
Section 3 Gas Adjustment and Maintenance of Experimental Bottles and Dishes ... +00 17.
The calculation of clonal growth in agarose ... +00 18
Section 5 Evaluation of Cell Transformation Data ... +00 19
Section VI Example of Standard Operating Procedures for Cell Transformation Test ... 1020
Section 7 Preparation of Cell Transformation Test Reagents ... 1032
Chapter V Reproductive Toxicology Test Methods under GLP Conditions ... 1
Chapter 37 Overview of Reproductive Toxicology Tests ... 1
Section 1 Progress in Methodology of Reproductive Toxicology Test ... 1
Section 2 GLP requirements ... 3
Section III Research Scheme Recommended by ICH-Joint Research ... 3
Section IV Methodological Issues ... 6
Chapter 38 Reproductive Toxicology Methods Conforming to GLP Regulations ... 13
Section one. In vivo evaluation of developmental toxicity of rodents before birth ... 13
In vitro teratogenic test-organ culture of midfacial tissue and secondary palate ... 26
In vivo model of male reproductive toxicology ... 33
Section IV Guiding Principles for Rodent Mating ... 40
Section 5 Histopathological Techniques of Male Reproductive System ... 45
Section 6 Testicular sperm counting program ... 54
Section 7 Study on Teratogenesis of Rat Embryos Cultured in Vitro ... 58
Section 8 Operation Procedures of Rats in Teratogenesis Test ... 65
Section 9 Operation Procedure of Teratogenesis Test-Rabbit ... 68
Section 10 Procedure for bone examination by eviscerating fetal rats and rabbits ... 7 1
Alizarin staining of fetal rabbits and rats in section1/kloc-0 ... 72
Section 12, Bone Examination Procedure for Fetal Rabbits and Fetal Rats ... 74
Section 13 Observation Procedure for Fixing Fetal Rats with Boone's Solution ... 75
Section 14 Observation Procedure for Fixing Fetal Rabbits with Boone's Solution ... 76
Section XV Dominant Lethal Test Procedure for Rats (Mice) ... 77
Section 16 Reproduction test procedures for the first generation of rats and mice ... 79
Section 17 Procedures for observing the morphology and behavior of rodent embryos ...
Section 18 Vaginal smear to determine whether mating is successful ... 83
Section 19 Reproduction Test: Production and Breastfeeding ... 83
Section 20 Fetal Sex Identification and Weighing (Rodent) Procedure ... 84
Section 2 1 weaning, random grouping, numbering and handling procedures of fetuses (rodents) ...
Section 22 Vaginal smear to determine estrous cycle-rats ... 86
Chapter 39 Quality Control and Inspection of Reproductive Toxicology Test ...
Section I Introduction 87
Section 2 Quality Assurance of Developmental and Reproductive Toxicity Tests ...
Section 3 Quality Problems and Quality Control Measures ... 92
Section IV Conclusion ... 95
Section V Summary of Reproductive and Developmental Toxicology Research —— Case 96
Chapter 40 Toxicological Terms of Reproductive Development ... 105
Chapter VI Cytotoxicology in Vitro ................................................................................................... 1 17
Chapter 41 Application of in vitro toxicology in drug safety evaluation ... 1 17.
Section 1 Overview ... 1 17
The second section in vitro test verification procedures ... 1 18
In-vitro test ... 1 19 was added to the procedures in the third section of management requirements.
Section 4 In vitro test is considered as the acceptance field ... 1 19.
Section 5 General guidelines for preclinical development of medical products ... 120
Section VI European Alternative Method Verification Center ... 120
Section VII Comparison of Advantages and Disadvantages of Toxicology Experiment in Vitro ... 120
Section 8 Application of Human Liver Tissue Culture Materials in Metabolic and Toxicological Studies ... 12 1
Section 9: Research progress of in vitro model of nephrotoxicity ... 123
Section 10 Application of Cardiovascular Cell Culture Technology in Pharmacology and Toxicology ... 126
Section1/Example of hepatocyte preparation-Isolation of intact hepatocytes by in-situ perfusion in experimental animals ... 128
Section 12 preparation of hepatocytes-perfusion after hepatectomy ... 13 1
Section 13 Cryopreservation of Hepatocytes ... 132
Application of hepatocyte culture in drug safety evaluation ... 133
Chapter 42 Mammalian Cell Tissue Culture Technology ... 5438+034
Section 1 Overview ... 134
Section II Aseptic Technology ... 134
Section III Pancreatic Digestion and Monolayer Cell Passage Procedure ... 137
Section IV Passage Procedure of Cells in Suspension Medium ... 138
Section 5 Cryopreservation Procedure of Human Cells Growing in Monolayer Medium ... 139
Section VI Cryopreservation Procedure for Growth Cells in Suspension Medium ... 140
Section 7 Procedures for Thawing and Resuscitation of Frozen Cells ... 140
Section 8 Procedure for Cell Count and Survival Rate Determination ... 14 1
Section 9 Supporting Test Procedures ... 142
Notes to section 10 ... 144
Chapter 43 in vitro detection methods of cytotoxicity ... 146
Section 1 General Rules for Cytotoxicity Test ... 146
Section 2 Standard Operating Procedures for Cell Survival Rate Determination ... 147
Section 3 reagents and solutions for detecting cytotoxicity ... 157
Section IV Comments ... 158
Section 5 Example of Standard Operating Procedure for Cytotoxicity Test ... 165
Section VI Basic Operating Procedures of Cytotoxicity Test ... 167
Article 7 Toxicological Statistics .......................................................................................................... 177
Chapter 44 Application of statistics in toxicological safety evaluation ... 177
Before the first festival ... 177
Section II Selection Principles of Statistical Methods ... 178
Section 3 Hypothesis test: single factor parameter test ... 18 1
Section IV Hypothesis Test of Classification and Grading Data ... 194
Section 5 Application of Data Analysis in Toxicology ... 202
Section VI Comprehensive Evaluation of Statistical and Biological Significance of Experimental Results ... 206
Chapter 45 Toxicological Safety Assessment: Poisoning Physiology and Statistics ... 207
Section 1 Common formats and terms of toxicology statistics ... 207
Section 2 Common Statistical Problems ... 2 12
Chapter 46 Statistical Analysis of Toxicology Test and Carcinogenesis Test of Developmental Reproduction ...
Section 1 Statistical Analysis of Developmental Reproductive Toxicology Test and Carcinogenesis Test ...
Statistical analysis of rodent carcinogenesis test in the second quarter ... 250
Article 8 Conforming to the principles of GLP examination management ... 254
Chapter 47 Management of Samples and Reference Materials under GLP Principle ...
The first part is an overview of the management of experimental products ...
Sample management standard operating procedure template in the second quarter ... 259
Article 9 Manage instruments and equipment according to the principle of GLP ...
Chapter 48 Overview of instrument and equipment management according to GLP principle ...
The first section GLP instruments and equipment management requirements ... 273
Section 2: SOP Drafting Guide for Management, Calibration and Maintenance of Instruments and Equipment ... 277
Section 3 standard operating procedures. 279 is used for instrument calibration and maintenance
Section 4 SOP- SOP development flow chart for instrument calibration and maintenance ... 282
Section 5 SOP Details-Writing SOP for Instrument Calibration and Maintenance SOP...285
Chapter 49 Computer Security and Management ... 288
The first section computer security 1- logic security ... 288
Section 2 Data Backup and Recovery of Computer System under GLP Condition ... 293
Section 3 Computer Security 3- System Archiving and Recovery ... 297
Chapter 50 Examples of Standard Operating Procedures for Instruments and Equipment ... 300
Article 10 Quality Assurance and Quality Control ... 3 10
Chapter 5 1 Quality Assurance Department and its responsibilities ... 3 10
Section 1 Overview of Quality Assurance Department and Its Responsibilities ... 3 10
Section 2 How to Establish Quality Control and Quality Assurance System ... 3 15
Section 3: Introduction to the Guiding Principles for Inspection and Audit of OECD Qualified Laboratories ... 3 19
Chapter 52 Inspection of Specific Toxicology Tests ... 327
Section 1 Responsibilities of Quality Assurance Department of GLP Compliance Non-clinical Research Institutions ...
Section 2 General Toxicology Quality Control ... 330
Section III Quality Control of Immunotoxicology ... 336
Section 4 Quality Control of Genetic Toxicology Research ...
Section 5 How to Audit Pathological Data ... 340
Section VI Pathological Quality Assurance of Carcinogenicity Research of Rodents ...
Section 7 Quality Control and Inspection of Clinical Pathology Laboratory ...
Section 8 Verification of Conformity to GLP Standards ... 348
Chapter 53 Examination Contents of Personnel of Non-clinical Safety Evaluation Institutions ... 357
The first section of the project manager's management and responsibilities 357
In the second quarter, the problems that need to be considered in the personnel assessment of experimental institutions ... 363
Article 11 Archive the research data according to the GLP principle ... 368
Chapter 54 Procedures for submitting materials according to GLP principles ...
Section 1 Overview ... 368
Section II Filing of Original Materials ... 370
Section III Guiding Principles for Electronic Data Archiving in Accordance with GLP Principles ... 376
Chapter 55 Examples of archiving standard operating procedures ... 38 1
The twelfth toxicology test design template ... 39 1
Chapter 56 Toxicology Test Scheme Template ... 39 1
Section 1 Requirements of GLP Regulation on Test Scheme ... 39 1
Section 2 Template of General Toxicity Test Scheme ... 393
Section III Template of Local Toxicity Test Scheme ... 398
Section IV Template of Genetic Toxicology Test Scheme ... 4 16
Section 5 Long-term Carcinogenesis Test of Rodents ... 4 18
Section VII Cytotoxicology Test Scheme in Vitro ... 424
Section 8 Safety Pharmacology Research Template ... 429
Article 13 Toxicological Kinetics ...
Chapter 57 the basic principle and application of non-clinical safety evaluation of drugs in toxicokinetics ..... 40/kloc-40 109.00000000005
Section 1 Overview of Toxicological Kinetics ... 434
Section II Research Indicators of Toxicology Dynamics ...
Section 3 Physiology, Toxicology and Kinetics (PBTK)...440
Section IV Application of Toxicological Kinetics ... 44 1
Section V Summary ... 453
Article 14. New technologies and methods ...
Chapter 58 the application of new technology in modern toxicology research ... 40/kloc-40 109.000000000005
Part I: the standard procedure and optimization of PCR ... 40080.00000000105
Section 2 Detection and quantification of radiolabeled protein in gels and blots ... 4619.00000000001
The third quarter northern spot analysis ... 468
Section 4 One-way protein SDS Gel Electrophoresis ... 476