| Autore |
Chidambaram Saravana Babu
|
| Pubbl/distr/stampa |
Singapore : , : Springer, , [2022]
|
| Descrizione fisica |
1 online resource (205 pages)
|
| Disciplina |
615.9
|
| Soggetto topico |
Toxicology
Laboratory manuals
|
| ISBN |
981-16-6092-1
981-16-6091-3
|
| Formato |
Materiale a stampa  |
| Livello bibliografico |
Monografia |
| Lingua di pubblicazione |
eng
|
| Nota di contenuto |
Intro -- Foreword -- Foreword -- Foreword -- Preface -- Acknowledgement -- Contents -- 1: Introduction to Toxicology -- 1.1 Definition -- 1.2 History -- 1.3 Types of Toxicology (Barile 2019) -- 1.3.1 Descriptive Toxicology -- 1.3.2 Mechanistic Toxicology -- 1.3.3 Clinical Toxicology -- 1.3.4 Forensic Toxicology -- 1.3.5 Regulatory Toxicology -- 1.4 Standard, Test Guidelines and Regulatory Bodies -- 1.4.1 Standards -- 1.4.2 Test Guidelines (TG) -- 1.5 Organisation for Economic Co-operation and Development (OECD) -- 1.5.1 Organisational Structure -- 1.5.2 The Council -- 1.5.3 The Secretariat -- 1.5.4 The Committees -- 1.5.5 Functions of OECD -- 1.5.6 OECD Guidelines for Testing for Chemicals -- 1.6 International Conference on Harmonisation (ICH) (ICH Guidelines for Pharmaceuticals: Pharmaceutical Guidelines n.d.) -- 1.6.1 History -- 1.6.2 ICH Organisational Structure and Functions -- 1.6.2.1 ICH Steering Committee -- 1.6.2.2 ICH Coordinators -- 1.6.2.3 ICH Secretariat -- 1.6.2.4 ICH Working Group -- 1.6.3 ICH Guidelines (ICH Official web site: ICH n.d.) -- 1.7 Environmental Protection Agency (EPA) -- 1.7.1 EPA Organization Structure (Fig. 1.3) -- 1.7.2 Functions -- 1.7.3 EPA Health Effects Test Guidelines -- 1.8 Central Drugs Standard Control Organisation -- 1.8.1 CDSCO Organisation System -- 1.8.2 Location of CDSCO and Associated Offices -- 1.8.3 Functions of CDSCO -- 1.9 Functions of State Licensing Authority -- 1.10 Schedule Y (Schedule Y(amended version) - CDSCO n.d.) -- 1.10.1 Scope -- 1.10.2 Non-Clinical Toxicity studies as per the Schedule-Y (Appendix-III) -- 1.10.2.1 Systemic Toxicity Studies (Schedule Y(amended version) - CDSCO n.d.) -- 1.10.2.2 Local Toxicity -- 1.10.2.3 Parenteral Drugs -- 1.10.2.4 Ocular Toxicity Studies -- 1.10.2.5 Inhalational Toxicity Studies -- 1.10.2.6 Allergenicity/Hypersensitivity -- 1.10.2.7 Genotoxicity.
1.10.2.8 Carcinogenicity -- References -- 2: Laboratory Animal Models -- 2.1 Definition -- 2.2 Types of Animal Models -- 2.3 History -- 2.4 Future of Animal Study -- 2.5 Animal Ethics -- 2.6 India -- 2.7 Functions of CPCSEA -- 2.8 Institutional Animals Ethics Committee (IAEC) -- 2.9 Composition of IAEC -- 2.10 Functions of IAEC -- 2.11 Laboratory Animals -- 2.11.1 Inbred Strain -- 2.11.2 F1 Hybrid -- 2.11.3 Outbred Strain -- 2.11.4 Stock Vs. Strain -- 2.11.5 Transgenic Animals -- 2.11.6 Selection of an Animal Model -- 2.11.7 Experiment Designing -- 2.11.8 Disease Models (Schønecker 2014) -- 2.12 Number of Animals per Group -- 2.13 Randomisation -- 2.14 Control Groups -- 2.14.1 Pilot Study -- 2.15 Physiological, Clinical Parameters of Laboratory Animal Models -- 2.15.1 Physiological Parameters -- 2.15.2 Blood Clinical Chemistry -- 2.15.3 Haematology -- 2.15.4 Serum Electrolytes -- References -- 3: Toxicological Screening Methods -- 3.1 Acute Oral Toxicity -- 3.1.1 Purpose -- 3.1.2 Definition -- 3.1.3 Principle -- 3.1.4 Procedure -- 3.1.5 Interpretation -- 3.2 Acute Oral Toxicity: Step-Up and Step-Down Procedure -- 3.2.1 Purpose -- 3.2.2 Definition -- 3.2.3 Principle -- 3.2.4 Interpretation -- 3.3 Acute Eye Irritation/Corrosion in Rabbit -- 3.3.1 Purpose -- 3.3.2 Principle -- 3.3.3 Procedure: (OECD GLP n.d.) -- 3.3.4 Grading of Ocular Lesions: (Table 3.1, 3.2, 3.3, and 3.4) -- 3.3.5 Interpretation -- 3.4 Acute Dermal Irritation/Corrosion -- 3.4.1 Purpose -- 3.4.2 Definitions -- 3.4.2.1 Dermal Irritation -- 3.4.2.2 Dermal Corrosion -- 3.4.3 Principle -- 3.4.4 Procedure: (OECD GLP n.d.) -- 3.4.5 Grading of Skin Reactions (Test No. 404 n.d.) (Tables 3.6, 3.7, and 3.8) -- 3.4.6 Interpretation -- 3.5 Acute Dermal Toxicity -- 3.5.1 Purpose -- 3.5.2 Definition -- 3.5.3 Principle -- 3.5.4 Interpretation.
3.6 Skin Sensitization Test (Guinea-Pig Maximization Test Method) -- 3.6.1 Purpose -- 3.6.2 Definition -- 3.6.3 Principle -- 3.6.4 Steady-State Experiment -- 3.6.4.1 Preparation of Test System -- 3.6.4.2 Pre-test -- 3.6.4.3 Main Study -- 3.6.4.4 Preparation of Injection Sites -- 3.6.5 Day-0/Intradermal injection -- 3.6.5.1 Control Group -- 3.6.5.2 Treated Group -- 3.6.5.3 Epidermal Application -- 3.6.5.4 Challenge Dose -- 3.6.5.5 Second Challenge -- 3.6.5.6 Observations -- 3.6.5.7 Skin Reactions -- 3.6.5.8 Readings and Scoring -- 3.6.5.9 Rating of Allergenicity -- 3.6.5.10 Necropsy -- 3.6.5.11 Histopathology -- 3.6.6 Interpretation -- 3.7 Acute Inhalation Toxicity -- 3.7.1 Preamble -- 3.7.2 Purpose -- 3.7.3 Definition -- 3.7.4 Principle -- 3.7.5 Traditional Protocol -- 3.7.6 Concentration x Time (C x T) Protocol -- 3.7.7 Interpretation -- 3.8 28/90 Day Repeated Oral Toxicity -- 3.8.1 Purpose -- 3.8.2 Definition -- 3.8.3 Principle -- 3.8.4 Observation -- 3.8.5 Data Interpretation -- 3.9 28-Day Inhalation Toxicity Study -- 3.9.1 Purpose -- 3.9.2 Definition -- 3.9.3 Principle -- 3.9.4 Observations -- 3.9.5 Data Interpretation -- 3.10 Neurotoxicity -- 3.10.1 Purpose -- 3.10.2 Definition -- 3.10.3 Principle -- 3.10.4 Observations: (Research 2020) -- 3.10.5 Data Interpretation -- 3.11 Carcinogenicity -- 3.11.1 Definition -- 3.11.2 Principle -- 3.11.3 Observation -- 3.11.4 Data Interpretation -- 3.12 Reproduction and Developmental Toxicity -- 3.12.1 Purpose -- 3.12.2 Definition -- 3.13 Fertility and Reproductive Performance Study (Segment I) -- 3.13.1 Purpose -- 3.13.2 Principle -- 3.13.3 Observations -- 3.13.4 Interpretation -- 3.14 Prenatal Developmental Toxicity Study (Segment II) -- 3.14.1 Purpose -- 3.14.2 Definition -- 3.14.3 Principle -- 3.14.4 Observations -- 3.14.5 Maternal Endpoints -- 3.14.5.1 Foetal Endpoints -- 3.14.6 Interpretation.
3.15 Extended One-Generation Reproductive Toxicity Study (EOGRTS) (Segment III) -- 3.15.1 Purpose -- 3.15.2 Principle -- 3.15.3 Steady State Experiment -- 3.15.3.1 Cohort-1A: Reproductive toxicity Assessment -- 3.15.3.2 Cohort-1B: Reproductive performance Assessment -- 3.15.3.3 Cohort-2: Neurotoxicity Assessment -- 3.15.3.4 Cohort-3: Immunotoxicity Assessment -- 3.15.4 Data Interpretation -- 3.16 Bacterial Reverse Mutation Test -- 3.16.1 Purpose -- 3.16.2 Definition -- 3.16.3 Principle -- 3.16.4 Study State Experiment -- 3.16.5 Data and Reporting -- 3.16.6 Interpretation -- 3.17 In Vivo Mammalian Erythrocyte Micronucleus Test -- 3.17.1 Purpose -- 3.17.2 Definition -- 3.17.3 Principle -- 3.17.4 Interpretation of Result -- 3.18 In Vitro Chromosomal Aberration Test -- 3.18.1 Purpose -- 3.18.2 Definition -- 3.18.3 Principle -- 3.18.3.1 Study State Experiment (Test No. 473 n.d., p. 473) -- 3.18.3.2 Experimental Design -- 3.18.3.3 Microscopic Analysis -- 3.18.3.4 Data Analysis -- 3.18.4 Interpretation -- References -- 4: Toxicokinetics -- 4.1 Purpose -- 4.2 Definition -- 4.3 Toxicokinetics in Various Systemic Toxicological Studies -- 4.4 Toxicokinetics Models -- 4.5 Orders of Kinetics -- 4.6 Factors Influencing Toxicokinetics -- 4.7 Study State Experiment (Test No. 417 n.d.) -- 4.8 Measurement of Parameters -- 4.9 Conclusion -- References -- 5: Safety Pharmacology -- 5.1 Purpose -- 5.2 Definition -- 5.2.1 ICH Test Guidelines for Non-clinical Safety Studies -- 5.2.2 Safety Pharmacology Tiers -- 5.2.3 Major Organ Systems Studied in Safety Pharmacology Are -- 5.2.4 Follow-Up and Supplemental Safety Pharmacology Studies -- 5.3 Cardiovascular Safety System (Champeroux et al. 2013) -- 5.3.1 Blood Pressure and Heart Rate Measurement -- 5.3.1.1 Procedure -- 5.3.2 Electrocardiogram -- 5.3.3 In-Vivo Telemetry Method -- 5.3.3.1 Procedure -- Internal Jacketed.
External Jacketed -- 5.3.4 In-Vitro hERG Assay -- 5.3.4.1 Purpose -- 5.3.4.2 Procedure -- 5.3.4.3 Interpretation -- 5.4 Central Nervous System Safety Pharmacology -- 5.4.1 Core Battery Tests (Porsolt et al. 2002) -- 5.4.1.1 Irwin Test -- 5.4.2 CNS Follows Up Studies: (Barile 2019) -- 5.4.2.1 Behavioural pharmacology -- 5.4.2.2 Learning and Memory -- 5.4.2.3 Visual Assessment of Rodents -- 5.4.2.4 Auditory Function Evaluation -- 5.5 Respiratory System Safety Pharmacology -- 5.5.1 Invasive Methods -- 5.5.1.1 Whole-Body Plethysmography -- 5.5.1.2 Blood Profile Analysis -- 5.6 Renal System Safety Pharmacology -- 5.6.1 Assessment of Glomerular Filtration Rate -- 5.6.1.1 Procedure -- 5.6.2 Evaluation of Tubular Function by Micropunctures -- 5.6.2.1 Procedure -- 5.6.3 Diuretic Activity in Rats (Lipschitz Test) -- 5.6.3.1 Procedure -- 5.7 Gastrointestinal (GI) Safety Pharmacology -- 5.7.1 Gastric Acid Secretion in Anesthetized Stomach-Lumen Perfused Rats -- 5.7.1.1 Procedure -- 5.7.2 Effect of the Test Item on Serum Gastrin Levels -- 5.7.2.1 Procedure -- 5.7.3 Bile Secretion in a Mouse Model -- 5.7.3.1 Purpose -- 5.7.3.2 Procedure -- 5.7.4 Bile Duct and Duodenum Cannulation Method -- 5.7.5 Exocrine Pancreatic Secretion in Anesthetized Rats -- 5.7.5.1 Purpose -- 5.7.5.2 Procedure -- 5.7.6 Gastrointestinal Injury -- 5.7.6.1 Purpose -- 5.7.6.2 Procedure -- 5.7.7 Gastric Ulceration: Pylorus Ligation Model in Rats -- 5.7.7.1 Purpose -- 5.7.7.2 Procedure -- References -- 6: Good Laboratory Practice -- 6.1 Definition -- 6.2 History -- 6.3 OECD Principles of Good Laboratory Practice -- 6.4 Scope of OECD GLP Principles -- 6.5 National GLP Compliance Monitoring Authority (NGCMA), Government of India -- 6.6 Responsibilities of GLP Personnel -- 6.7 Test System and Test Item Characterization -- 6.7.1 Test System -- 6.7.2 Test Item and Reference Item -- 6.8 OECD Documents.
References.
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| Record Nr. | UNINA-9910743243003321 |
Info
Introduction to toxicological screening methods and good laboratory practice / / Saravana Babu Chidambaram, M. Mohamed Essa, M. Walid Qoronfleh
