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Mammalian Toxicology.

By: Material type: TextTextSeries: New York Academy of Sciences SeriesPublisher: Newark : John Wiley & Sons, Incorporated, 2015Copyright date: ©2015Edition: 1st edDescription: 1 online resource (718 pages)Content type:
  • text
Media type:
  • computer
Carrier type:
  • online resource
ISBN:
  • 9781118682852
Subject(s): Genre/Form: Additional physical formats: Print version:: Mammalian ToxicologyDDC classification:
  • 591.7/14
LOC classification:
  • QL739.2 .M366 2015
Online resources:
Contents:
Intro -- Mammalian Toxicology -- About the Editor -- Contents -- List of Contributors -- Acknowledgments -- Introduction -- Toxicants -- Toxic Entities -- Hazardous Chemicals -- Greenhouse Gases -- Carbon Dioxide -- Methane -- Nitrous Oxide -- Fluorinated Gases -- Ozone -- Acid Rain -- Human Diseases and Exposure to Chemicals -- Alzheimers Disease (AD) and Parkinsons Disease (PD) -- Oxidative Stress -- Overview -- A Description of the Book -- 1 General Principles -- 1.1 Introduction -- 1.1.1 Definition of Toxicology -- 1.1.2 Toxicological Studies -- 1.1.3 Accreditation in Toxicology -- 1.1.4 Societies of Toxicology -- 1.2 Toxic Responses to Xenobiotics -- 1.2.1 Molecular Changes -- 1.2.2 Subcellular Changes -- 1.2.3 Cellular Changes -- 1.2.4 Allergic or Sensitization Reactions -- 1.2.5 Idiosyncrasy -- 1.3 Evaluation of Chemical-Induced Diseases -- 1.3.1 Strength -- 1.3.2 Consistency -- 1.3.3 Specificity -- 1.3.4 Temporality -- 1.3.5 Biological Gradient -- 1.3.6 Plausibility -- 1.3.7 Coherence -- 1.3.8 Experiment -- 1.3.9 Analogy -- 1.3.10 Differential Diagnosis -- 1.4 Toxicological Studies -- 1.4.1 Definitions -- 1.4.2 Evaluation of Toxicity -- 1.4.3 Therapeutic Index (IT) -- 1.5 Toxicological Studies -- 1.5.1 Test Compound -- 1.5.2 Impurities -- 1.5.3 Dose -- 1.5.4 Animals -- 1.5.5 Temperature -- 1.5.6 Diet -- 1.5.7 Controls -- 1.5.8 Parameters Recorded in Acute Toxicity Studies -- 1.6 Acute Toxicity -- 1.6.1 Methods for Evaluating Acute Toxicity -- References -- 2 Alternatives to In-Vivo Studies in Toxicology -- 2.1 Introduction -- 2.2 Test Systems: Characteristics, Development, and Selection -- 2.3 In-Vitro Models -- 2.3.1 Tissue Culture -- 2.4 Lethality Testing -- 2.4.1 Lethality Testing in Lower-Species Animals -- 2.4.2 Ocular Irritation -- 2.4.3 Dermal Irritation -- 2.4.4 Irritation of Parenterally Administered Pharmaceuticals.
2.4.5 Sensitization and Photosensitization -- 2.4.6 Phototoxicity and Photosensitization -- 2.4.7 Developmental Toxicity -- 2.4.8 Target Organ Toxicity Models -- 2.5 In-Silico Methods -- 2.6 The Final Frontier and Barrier: Regulatory Acceptance -- 2.7 Conclusions -- References -- Further Reading -- 3 The Application of Omics Technologies to the Study of Mammalian Toxicology -- 3.1 Introduction -- 3.2 Genomics -- 3.2.1 Technologies Used in Genomics -- 3.2.2 Approaches in Genomics -- 3.2.3 Applications of Genomics -- 3.3 Epigenomics -- 3.3.1 Technologies Used in Epigenomics -- 3.3.2 Approaches in Epigenomics -- 3.3.3 Applications of Epigenomics -- 3.4 Transcriptomics -- 3.4.1 Technologies Used in Transcriptomics -- 3.4.2 Approaches to Transcriptomics -- 3.4.3 Applications of Transcriptomics -- 3.5 Proteomics -- 3.5.1 Technologies Used in Proteomics -- 3.5.2 Approaches to Proteomics -- 3.5.3 Applications of Proteomics -- 3.6 Metabolomics -- 3.6.1 Technologies Used in Metabolomics -- 3.6.2 Approaches to Metabolomics -- 3.6.3 Applications of Metabolomics -- 3.7 Systems Toxicology -- 3.7.1 Applications of Systems Toxicology -- 3.8 Analysis of Omics Data -- 3.9 Conclusion -- References -- 4 Cell Death Pathways in Toxicological Response -- 4.1 Tissue Homeostasis -- 4.2 Death Is the Default -- 4.3 Forms of Cell Death -- 4.4 The Key Constituents of Apoptosis -- 4.4.1 Caspases -- 4.5 Mitochondria and Bcl-2 Family Proteins -- 4.6 The Apoptosome -- 4.7 Extrinsic and Intrinsic Apoptosis -- 4.8 Toxins Kill Cells by Activating Apoptotic Pathways -- 4.9 Toxins Can Also Trigger a Cells Survival Response -- 4.10 Outcomes of Cell Death on Tissues -- 4.11 Toxicological Regulation of Cell Death: An Overview -- References -- 5 Principles of Toxicokinetics and Predictive Toxicokinetics Modeling -- 5.1 Introduction -- 5.2 Absorption -- 5.2.1 Oral Absorption.
5.2.2 Inhalational Absorption -- 5.2.3 Dermal Absorption -- 5.3 Distribution -- 5.3.1 Oral Dosing -- 5.3.2 Inhalation Dosing -- 5.3.3 Dermal Dosing -- 5.3.4 Distribution within Tissues -- 5.3.5 Perfusion- and Diffusion-Limitation -- 5.4 Metabolism -- 5.5 Excretion -- 5.5.1 Urinary Excretion -- 5.5.2 Fecal Excretion -- 5.5.3 Exhalation -- 5.5.4 Sweat -- 5.5.5 Lactation -- 5.6 Pharmacokinetic Predictive Modeling -- 5.6.1 One-Compartment Models -- 5.6.2 Multi-Compartment Models -- 5.6.3 Physiologically Based Pharmacokinetic (PBPK) Models -- 5.7 Toxicokinetics: Applications to Human Health Risk Assessment -- References -- 6 Metabolic Biotransformation of Xenobiotics -- 6.1 Introduction -- 6.1.1 Tissue Localization of Xenobiotic-Metabolizing Enzymes -- 6.1.2 Reactions of Metabolic Biotransformation -- 6.2 Xenobiotic-Metabolizing Reactions: Phase I -- 6.2.1 Cytochrome P450 (Microsomal Mixed-Function Oxidase, MFO) -- 6.2.2 Cytochrome P450-Mediated Reactions -- 6.2.3 Reactions Other Than Microsomal Mixed-Function Oxidase -- 6.3 Xenobiotic-Metabolizing Reactions: Phase II -- 6.3.1 Conjugation with Sugars -- 6.3.2 Sulfation -- 6.3.3 Glutathione Conjugation -- 6.3.4 Other Conjugation Reactions -- 6.3.5 Phase II Metabolism of Endogenous Compounds -- References -- 7 Pesticides -- 7.1 Introduction -- 7.2 Insecticides -- 7.2.1 Axonal Transmission as an Insecticidal Target -- 7.2.2 The Synapse as an Insecticidal Target -- 7.3 Mitochondrial Injury -- 7.3.1 Organophosphorus Ester-Induced Chronic Neurotoxicity (OPICN) -- 7.4 Herbicides -- 7.4.1 Health Effects of Herbicides -- 7.4.2 Chlorophenoxy Acetic Acid Herbicides -- 7.4.3 Nitrophenolic and Chlorophenolic Herbicides -- 7.4.4 Dipyridyl Herbicides -- 7.4.5 Chlorate Salts -- 7.4.6 Atrazine -- 7.4.7 Organophosphate Herbicides -- 7.5 Fungicides -- 7.5.1 Thiocarbamates and Dithiocarbamates -- 7.5.2 Phthalimides.
7.5.3 Hexachlorophene -- 7.6 Rodenticides -- 7.6.1 Anticoagulants -- 7.6.2 Sodium Monofluoroacetate (1080) -- 7.6.3 Zinc Phosphide -- 7.6.4 Strychnine -- 7.7 Insect Repellents -- 7.7.1 DEET -- 7.8 Combined Pesticide Exposure -- 7.9 Stress and Pesticide Toxicity -- 7.10 Pesticide Formulations and Inert Ingredients -- 7.10.1 Dusts -- 7.10.2 Wettable Powders (WPs) -- 7.10.3 Emulsifiable Concentrates (ECs) -- 7.10.4 Suspendable Concentrates (CSs) or Flowables -- 7.10.5 Water-Soluble Powders (SPs) -- 7.10.6 Solutions -- 7.10.7 Granules -- 7.10.8 Water-Dispersible Granules (WGs) -- 7.10.9 Ultra-Low-Volume (ULV) -- 7.10.10 Aerosols -- 7.10.11 Controlled Release (CR) Formulations -- 7.10.12 Baits -- References -- 8 Metal Toxicology -- 8.1 Introduction -- 8.2 Human Health Effects -- 8.2.1 Types of Health Effect -- 8.2.2 Trace Metals -- 8.2.3 Administration: Routes of Exposure -- 8.2.4 Transport and Distribution: The Systemic Toxicity of Metals -- 8.2.5 Biotransformation (Metabolism) -- 8.2.6 Elimination -- 8.3 Properties of Metals -- 8.3.1 Determinants of Reactivity -- 8.3.2 Mechanisms of Action -- 8.4 Methodologies -- 8.4.1 Administration of Metals in Mammalian Systems -- 8.4.2 Detection of Metals -- 8.5 Conclusions -- Acknowledgments -- References -- 9 Organic Solvents -- 9.1 Introduction -- 9.2 Occupational Exposures -- 9.3 Environmental Exposures -- 9.4 Toxicokinetics -- 9.4.1 Absorption -- 9.4.2 Transport and Distribution -- 9.4.3 Metabolism -- 9.4.4 Elimination -- 9.5 Aromatic Hydrocarbons -- 9.5.1 Benzene -- 9.5.2 Toluene -- 9.5.3 Styrene -- 9.6 Aliphatic Hydrocarbons -- 9.6.1 The Chemical Class -- 9.6.2 n-Hexane -- 9.7 Halogenated Aliphatic Hydrocarbons -- 9.7.1 Methylene Chloride -- 9.7.2 Chloroform -- 9.7.3 Carbon Tetrachloride -- 9.7.4 Trichloroethylene -- 9.7.5 Tetrachloroethylene -- References -- 10 Gases -- 10.1 Introduction.
10.1.1 Threshold Limit Value (TLV) -- 10.2 Action of Gases -- 10.3 Simple Asphyxiants -- 10.3.1 Carbon Dioxide (CO2) -- 10.4 Toxic Asphyxiants -- 10.4.1 Carbon Monoxide (CO) -- 10.4.2 Cyanide -- 10.4.3 Hydrogen Sulfide -- 10.4.4 Other Methemoglobinemia-Producing Chemicals -- 10.5 Gases Affecting the CNS and PNS -- 10.5.1 Carbon Disulfide -- 10.6 Irritants -- 10.6.1 Ammonia -- 10.6.2 Chlorine -- 10.6.3 Air Pollutants -- 10.6.4 Oxides of Sulfur (SOx) -- 10.6.5 Oxides of Nitrogen -- 10.6.6 Ozone -- 10.6.7 Formaldehyde -- 10.7 Sensitizers -- 10.7.1 Methyl Isocyanate -- 10.7.2 Toluene 2,4-Diisocyanate -- References -- 11 Nanotoxicology: Environmental, Health and Safety (EHS) Considerations for Assessing Hazards and Risks Following Nanoparticle Exposures -- 11.1 Introduction -- 11.2 Importance of Physico-Chemical Characterization Studies on Nanoparticle-Types -- 11.3 Species Differences in Lung Responses to Inhaled Fine and/or Ultrafine TiO2 Particles -- 11.4 Strategies for Assessing Pulmonary Hazards to Nanomaterials -- 11.4.1 Pulmonary Bioassay Studies of Fine and Nanoscale TiO2 Particle-types -- 11.4.2 Pulmonary Bioassay Studies of Fine and Nanoscale a-Quartz Particle-Types -- 11.5 Evaluating the Risks Associated with Nanomaterial Exposures: The NanoRisk Framework -- 11.6 Safe Handling of Nanomaterials in the Laboratory -- 11.7 Conclusions -- References -- 12 Pharmaceutical Toxicity In Humans -- 12.1 Introduction -- 12.1.1 Evolution of the Study and Understanding of Pharmaceutical Toxicity -- 12.1.2 Regulatory Overview of Pharmaceutical Safety -- 12.1.3 Pharmaceutical Decision-Making in Drug Development -- 12.1.4 History of Drug Regulation in the US -- 12.1.5 Definitions of Toxicity -- 12.1.6 Preclinical Testing -- 12.1.7 Clinical Studies and Toxicity -- 12.1.8 Adverse Events -- 12.1.9 Serious Adverse Events -- 12.1.10 Risk : Benefit Analysis.
12.2 Development of Pharmaceuticals to Ensure their Safe Use.
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Intro -- Mammalian Toxicology -- About the Editor -- Contents -- List of Contributors -- Acknowledgments -- Introduction -- Toxicants -- Toxic Entities -- Hazardous Chemicals -- Greenhouse Gases -- Carbon Dioxide -- Methane -- Nitrous Oxide -- Fluorinated Gases -- Ozone -- Acid Rain -- Human Diseases and Exposure to Chemicals -- Alzheimers Disease (AD) and Parkinsons Disease (PD) -- Oxidative Stress -- Overview -- A Description of the Book -- 1 General Principles -- 1.1 Introduction -- 1.1.1 Definition of Toxicology -- 1.1.2 Toxicological Studies -- 1.1.3 Accreditation in Toxicology -- 1.1.4 Societies of Toxicology -- 1.2 Toxic Responses to Xenobiotics -- 1.2.1 Molecular Changes -- 1.2.2 Subcellular Changes -- 1.2.3 Cellular Changes -- 1.2.4 Allergic or Sensitization Reactions -- 1.2.5 Idiosyncrasy -- 1.3 Evaluation of Chemical-Induced Diseases -- 1.3.1 Strength -- 1.3.2 Consistency -- 1.3.3 Specificity -- 1.3.4 Temporality -- 1.3.5 Biological Gradient -- 1.3.6 Plausibility -- 1.3.7 Coherence -- 1.3.8 Experiment -- 1.3.9 Analogy -- 1.3.10 Differential Diagnosis -- 1.4 Toxicological Studies -- 1.4.1 Definitions -- 1.4.2 Evaluation of Toxicity -- 1.4.3 Therapeutic Index (IT) -- 1.5 Toxicological Studies -- 1.5.1 Test Compound -- 1.5.2 Impurities -- 1.5.3 Dose -- 1.5.4 Animals -- 1.5.5 Temperature -- 1.5.6 Diet -- 1.5.7 Controls -- 1.5.8 Parameters Recorded in Acute Toxicity Studies -- 1.6 Acute Toxicity -- 1.6.1 Methods for Evaluating Acute Toxicity -- References -- 2 Alternatives to In-Vivo Studies in Toxicology -- 2.1 Introduction -- 2.2 Test Systems: Characteristics, Development, and Selection -- 2.3 In-Vitro Models -- 2.3.1 Tissue Culture -- 2.4 Lethality Testing -- 2.4.1 Lethality Testing in Lower-Species Animals -- 2.4.2 Ocular Irritation -- 2.4.3 Dermal Irritation -- 2.4.4 Irritation of Parenterally Administered Pharmaceuticals.

2.4.5 Sensitization and Photosensitization -- 2.4.6 Phototoxicity and Photosensitization -- 2.4.7 Developmental Toxicity -- 2.4.8 Target Organ Toxicity Models -- 2.5 In-Silico Methods -- 2.6 The Final Frontier and Barrier: Regulatory Acceptance -- 2.7 Conclusions -- References -- Further Reading -- 3 The Application of Omics Technologies to the Study of Mammalian Toxicology -- 3.1 Introduction -- 3.2 Genomics -- 3.2.1 Technologies Used in Genomics -- 3.2.2 Approaches in Genomics -- 3.2.3 Applications of Genomics -- 3.3 Epigenomics -- 3.3.1 Technologies Used in Epigenomics -- 3.3.2 Approaches in Epigenomics -- 3.3.3 Applications of Epigenomics -- 3.4 Transcriptomics -- 3.4.1 Technologies Used in Transcriptomics -- 3.4.2 Approaches to Transcriptomics -- 3.4.3 Applications of Transcriptomics -- 3.5 Proteomics -- 3.5.1 Technologies Used in Proteomics -- 3.5.2 Approaches to Proteomics -- 3.5.3 Applications of Proteomics -- 3.6 Metabolomics -- 3.6.1 Technologies Used in Metabolomics -- 3.6.2 Approaches to Metabolomics -- 3.6.3 Applications of Metabolomics -- 3.7 Systems Toxicology -- 3.7.1 Applications of Systems Toxicology -- 3.8 Analysis of Omics Data -- 3.9 Conclusion -- References -- 4 Cell Death Pathways in Toxicological Response -- 4.1 Tissue Homeostasis -- 4.2 Death Is the Default -- 4.3 Forms of Cell Death -- 4.4 The Key Constituents of Apoptosis -- 4.4.1 Caspases -- 4.5 Mitochondria and Bcl-2 Family Proteins -- 4.6 The Apoptosome -- 4.7 Extrinsic and Intrinsic Apoptosis -- 4.8 Toxins Kill Cells by Activating Apoptotic Pathways -- 4.9 Toxins Can Also Trigger a Cells Survival Response -- 4.10 Outcomes of Cell Death on Tissues -- 4.11 Toxicological Regulation of Cell Death: An Overview -- References -- 5 Principles of Toxicokinetics and Predictive Toxicokinetics Modeling -- 5.1 Introduction -- 5.2 Absorption -- 5.2.1 Oral Absorption.

5.2.2 Inhalational Absorption -- 5.2.3 Dermal Absorption -- 5.3 Distribution -- 5.3.1 Oral Dosing -- 5.3.2 Inhalation Dosing -- 5.3.3 Dermal Dosing -- 5.3.4 Distribution within Tissues -- 5.3.5 Perfusion- and Diffusion-Limitation -- 5.4 Metabolism -- 5.5 Excretion -- 5.5.1 Urinary Excretion -- 5.5.2 Fecal Excretion -- 5.5.3 Exhalation -- 5.5.4 Sweat -- 5.5.5 Lactation -- 5.6 Pharmacokinetic Predictive Modeling -- 5.6.1 One-Compartment Models -- 5.6.2 Multi-Compartment Models -- 5.6.3 Physiologically Based Pharmacokinetic (PBPK) Models -- 5.7 Toxicokinetics: Applications to Human Health Risk Assessment -- References -- 6 Metabolic Biotransformation of Xenobiotics -- 6.1 Introduction -- 6.1.1 Tissue Localization of Xenobiotic-Metabolizing Enzymes -- 6.1.2 Reactions of Metabolic Biotransformation -- 6.2 Xenobiotic-Metabolizing Reactions: Phase I -- 6.2.1 Cytochrome P450 (Microsomal Mixed-Function Oxidase, MFO) -- 6.2.2 Cytochrome P450-Mediated Reactions -- 6.2.3 Reactions Other Than Microsomal Mixed-Function Oxidase -- 6.3 Xenobiotic-Metabolizing Reactions: Phase II -- 6.3.1 Conjugation with Sugars -- 6.3.2 Sulfation -- 6.3.3 Glutathione Conjugation -- 6.3.4 Other Conjugation Reactions -- 6.3.5 Phase II Metabolism of Endogenous Compounds -- References -- 7 Pesticides -- 7.1 Introduction -- 7.2 Insecticides -- 7.2.1 Axonal Transmission as an Insecticidal Target -- 7.2.2 The Synapse as an Insecticidal Target -- 7.3 Mitochondrial Injury -- 7.3.1 Organophosphorus Ester-Induced Chronic Neurotoxicity (OPICN) -- 7.4 Herbicides -- 7.4.1 Health Effects of Herbicides -- 7.4.2 Chlorophenoxy Acetic Acid Herbicides -- 7.4.3 Nitrophenolic and Chlorophenolic Herbicides -- 7.4.4 Dipyridyl Herbicides -- 7.4.5 Chlorate Salts -- 7.4.6 Atrazine -- 7.4.7 Organophosphate Herbicides -- 7.5 Fungicides -- 7.5.1 Thiocarbamates and Dithiocarbamates -- 7.5.2 Phthalimides.

7.5.3 Hexachlorophene -- 7.6 Rodenticides -- 7.6.1 Anticoagulants -- 7.6.2 Sodium Monofluoroacetate (1080) -- 7.6.3 Zinc Phosphide -- 7.6.4 Strychnine -- 7.7 Insect Repellents -- 7.7.1 DEET -- 7.8 Combined Pesticide Exposure -- 7.9 Stress and Pesticide Toxicity -- 7.10 Pesticide Formulations and Inert Ingredients -- 7.10.1 Dusts -- 7.10.2 Wettable Powders (WPs) -- 7.10.3 Emulsifiable Concentrates (ECs) -- 7.10.4 Suspendable Concentrates (CSs) or Flowables -- 7.10.5 Water-Soluble Powders (SPs) -- 7.10.6 Solutions -- 7.10.7 Granules -- 7.10.8 Water-Dispersible Granules (WGs) -- 7.10.9 Ultra-Low-Volume (ULV) -- 7.10.10 Aerosols -- 7.10.11 Controlled Release (CR) Formulations -- 7.10.12 Baits -- References -- 8 Metal Toxicology -- 8.1 Introduction -- 8.2 Human Health Effects -- 8.2.1 Types of Health Effect -- 8.2.2 Trace Metals -- 8.2.3 Administration: Routes of Exposure -- 8.2.4 Transport and Distribution: The Systemic Toxicity of Metals -- 8.2.5 Biotransformation (Metabolism) -- 8.2.6 Elimination -- 8.3 Properties of Metals -- 8.3.1 Determinants of Reactivity -- 8.3.2 Mechanisms of Action -- 8.4 Methodologies -- 8.4.1 Administration of Metals in Mammalian Systems -- 8.4.2 Detection of Metals -- 8.5 Conclusions -- Acknowledgments -- References -- 9 Organic Solvents -- 9.1 Introduction -- 9.2 Occupational Exposures -- 9.3 Environmental Exposures -- 9.4 Toxicokinetics -- 9.4.1 Absorption -- 9.4.2 Transport and Distribution -- 9.4.3 Metabolism -- 9.4.4 Elimination -- 9.5 Aromatic Hydrocarbons -- 9.5.1 Benzene -- 9.5.2 Toluene -- 9.5.3 Styrene -- 9.6 Aliphatic Hydrocarbons -- 9.6.1 The Chemical Class -- 9.6.2 n-Hexane -- 9.7 Halogenated Aliphatic Hydrocarbons -- 9.7.1 Methylene Chloride -- 9.7.2 Chloroform -- 9.7.3 Carbon Tetrachloride -- 9.7.4 Trichloroethylene -- 9.7.5 Tetrachloroethylene -- References -- 10 Gases -- 10.1 Introduction.

10.1.1 Threshold Limit Value (TLV) -- 10.2 Action of Gases -- 10.3 Simple Asphyxiants -- 10.3.1 Carbon Dioxide (CO2) -- 10.4 Toxic Asphyxiants -- 10.4.1 Carbon Monoxide (CO) -- 10.4.2 Cyanide -- 10.4.3 Hydrogen Sulfide -- 10.4.4 Other Methemoglobinemia-Producing Chemicals -- 10.5 Gases Affecting the CNS and PNS -- 10.5.1 Carbon Disulfide -- 10.6 Irritants -- 10.6.1 Ammonia -- 10.6.2 Chlorine -- 10.6.3 Air Pollutants -- 10.6.4 Oxides of Sulfur (SOx) -- 10.6.5 Oxides of Nitrogen -- 10.6.6 Ozone -- 10.6.7 Formaldehyde -- 10.7 Sensitizers -- 10.7.1 Methyl Isocyanate -- 10.7.2 Toluene 2,4-Diisocyanate -- References -- 11 Nanotoxicology: Environmental, Health and Safety (EHS) Considerations for Assessing Hazards and Risks Following Nanoparticle Exposures -- 11.1 Introduction -- 11.2 Importance of Physico-Chemical Characterization Studies on Nanoparticle-Types -- 11.3 Species Differences in Lung Responses to Inhaled Fine and/or Ultrafine TiO2 Particles -- 11.4 Strategies for Assessing Pulmonary Hazards to Nanomaterials -- 11.4.1 Pulmonary Bioassay Studies of Fine and Nanoscale TiO2 Particle-types -- 11.4.2 Pulmonary Bioassay Studies of Fine and Nanoscale a-Quartz Particle-Types -- 11.5 Evaluating the Risks Associated with Nanomaterial Exposures: The NanoRisk Framework -- 11.6 Safe Handling of Nanomaterials in the Laboratory -- 11.7 Conclusions -- References -- 12 Pharmaceutical Toxicity In Humans -- 12.1 Introduction -- 12.1.1 Evolution of the Study and Understanding of Pharmaceutical Toxicity -- 12.1.2 Regulatory Overview of Pharmaceutical Safety -- 12.1.3 Pharmaceutical Decision-Making in Drug Development -- 12.1.4 History of Drug Regulation in the US -- 12.1.5 Definitions of Toxicity -- 12.1.6 Preclinical Testing -- 12.1.7 Clinical Studies and Toxicity -- 12.1.8 Adverse Events -- 12.1.9 Serious Adverse Events -- 12.1.10 Risk : Benefit Analysis.

12.2 Development of Pharmaceuticals to Ensure their Safe Use.

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