e9780124157590v1.pdf -- Front Cover -- Haschek and Rousseaux's Handbook of Toxicologic Pathology -- Copyright -- Dedication -- Contents -- Preface to the Third Edition -- About the Editors -- Editors -- Associate Editors -- Illustrations Editor -- Contributors -- Toxicologic Pathology: An Introduction -- VOLUME I - PRACTICE OF TOXICOLOGIC PATHOLOGY -- PART 1 - PRINCIPLES OF TOXICOLOGIC PATHOLOGY -- Chapter 1 - Biochemical and Molecular Basis of Toxicity -- 1. INTRODUCTION -- 2. GENERAL PRINCIPLES OF XENOBIOTIC DISPOSITION -- 3. INTERACTIONS OF TOXICANTS WITH CELLULAR AND MOLECULAR TARGETS -- 4. PROTECTIVE MECHANISMS, REPAIR MECHANISMS AND ADAPTATION -- 5. SUMMARY AND CONCLUSIONS -- Suggested Reading -- Chapter 2 - Pharmacokinetics and Toxicokinetics -- 1. INTRODUCTION -- 2. PHARMACOKINETICS: PROCESSES AND DETERMINANTS -- 3. PHARMACOKINETIC (TIME-COURSE) DATA AND DERIVATION OF DOSE METRICS -- 4. PHARMACOKINETIC MODELS AND COMPUTATION OF DOSE METRICS -- 5. PHARMACOKINETICS AND ITS USE IN DESIGNING TOXICITY STUDIES -- 6. PHARMACOKINETICS AND INTERPRETATION OF BIOASSAY OUTCOMES -- 7. CONCLUDING REMARKS -- Suggested Reading -- Chapter 3 - Principles of Pharmacodynamics and Toxicodynamics -- 1. INTRODUCTION: PHARMACODYNAMICS AND TOXICODYNAMICS DEFINED -- 2. RELEVANCE OF PD AND TD TO TOXICOLOGICAL PATHOLOGY -- 3. MECHANISMS OF DRUG ACTION: GENERAL CATEGORIES -- 4. CELLULAR PROCESSES LINKING DRUG CONCENTRATION AND RECEPTOR BINDING TO CELLULAR EFFECT -- 5. CHARACTERIZING BIOLOGICAL EFFECTS OF A DRUG OR TOXIN -- 6. REVERSIBLE TWO-STATE MODEL OF RECEPTOR ACTIVATION -- 7. SELECTIVITY AND SAFETY: THERAPEUTIC VS TOXIC EFFECT OF DRUGS -- 8. PRINCIPLES OF PHARMACOKINETIC/PHARMACODYNAMIC (PK/PD) MODELING -- 9. SUMMARY -- Suggested Reading -- Chapter 4 - Morphologic Manifestations of Toxic Cell Injury -- 1. INTRODUCTION -- 2. REVERSIBLE CELL INJURY.

3. IRREVERSIBLE INJURY -- 4. CONCLUDING COMMENTS -- Acknowledgements -- SUGGESTED READING -- Chapter 5 - Carcinogenesis: Mechanisms and Manifestations -- 1. INTRODUCTION -- 2. CANCER IS A GENETIC DISEASE -- 3. IDENTIFYING CARCINOGENS -- 4. CONCLUSIONS -- Acknowledgments -- Suggested Reading -- PART 2 - METHODS IN TOXICOLOGIC PATHOLOGY -- Chapter 6 - Basic Approaches in Anatomic Toxicologic Pathology -- 1. INTRODUCTION -- 2. GENERAL CONSIDERATIONS IN STUDY PROTOCOL DEVELOPMENT -- 3. IN-LIFE -- 4. NECROPSY -- 5. FIXATION AND HISTOLOGIC PROCEDURES -- 6. SPECIALIZED HISTOLOGIC TECHNIQUES -- 7. HISTOPATHOLOGY -- 8. ARTIFACTS VERSUS LESIONS -- 9. LESION INTERPRETATION -- 10. CONCLUSIONS -- SUGGESTED READING -- Chapter 7 - Special Techniques in Toxicologic Pathology -- 1. INTRODUCTION -- 2. IMMUNOHISTOCHEMISTRY -- 3. IN SITU HYBRIDIZATION (ISH) -- 4. FLOW CYTOMETRY -- 5. LASER MICRODISSECTION -- 6. CONFOCAL MICROSCOPY -- 7. DIGITAL PATHOLOGY -- SUGGESTED READING -- Chapter 8 - Stereological Principles and Sampling Procedures for Toxicologic Pathologists -- 1. APPLICATION OF DESIGN-BASED STEREOLOGY IN TOXICOLOGIC PATHOLOGY -- 2. STEREOLOGY - BASIC CONCEPTS AND SAMPLING DESIGNS -- 3. THE STEREOLOGICAL ESTIMATORS OF STRUCTURAL 3D QUANTITIES -- 4. OPTIMIZING THE SAMPLING PROCEDURE IN A GIVEN EXPERIMENT -- Acknowledgment -- APPENDICES -- Suggested Reading -- Chapter 9 - In Vivo Small Animal Imaging: A Comparison with Gross and Histopathologic Observations in Animal Models -- 1. INTRODUCTION -- 2. MAGNETIC RESONANCE IMAGING (MRI) AND MAGNETIC RESONANCE MICROSCOPY (MRM) -- 3. COMPUTED TOMOGRAPHY (CT) -- 4. MICRO-CT MICROSCOPY -- 5. RADIONUCLIDE-BASED IMAGING: PET AND SPECT -- 6. OPTICAL IMAGING -- 7. ULTRASOUND -- 8. TRANSLATIONAL APPLICATION, SAFETY ASSESSMENT, AND DRUG SCREENING WITH IN VIVO OR EX VIVO IMAGING -- Acknowledgments -- Suggested Reading.

Chapter 10 - Biomarkers: Discovery, Qualification and Application -- 1. INTRODUCTION -- 2. CATEGORIES OF BIOMARKERS -- 3. STRATEGIES FOR DISCOVERY OF BIOMARKERS -- 4. METHODS FOR BIOMARKER MEASUREMENT AND QUANTITATION -- 5. QUALIFICATION OF BIOMARKERS: MAJOR CONSIDERATIONS -- SUGGESTED READING -- Chapter 11 - The Application of Toxicogenomics to the Interpretation of Toxicologic Pathology -- 1. INTRODUCTION -- 2. WHY TOXICOGENOMICS? -- 3. KEY STRENGTHS AND WEAKNESSES OF TOXICOGENOMICS -- 4. TERMINOLOGY AND PLATFORMS FOR TOXICOGENOMICS -- 5. KEY ISSUES IN CONDUCTING TOXICOGENOMIC STUDIES -- 6. EXAMPLES OF KEY TOXICOGENOMIC STUDIES -- 7. DIRECTIONS OF TOXICOGENOMICS FOR THE NEXT DECADE -- ADDITIONAL DATA -- SUGGESTED READING -- Chapter 12 - Genetically Engineered Animals in Product Discovery and Development -- 1. FUNDAMENTALS OF GENETICALLY ENGINEERED ANIMAL MODELS -- 2. ANALYSIS OF GENETICALLY ENGINEERED ANIMAL MODELS -- 3. GENETICALLY MODIFIED MODELS FOR NON-CLINICAL SAFETY ASSESSMENT -- 4. LIMITATIONS IN USING GENETICALLY MODIFIED ANIMALS FOR NON-CLINICAL SAFETY TESTING -- 5. SPECIAL CONSIDERATIONS IN SAFETY ASSESSMENT OF PRODUCTS DERIVED FROM GENETICALLY ENGINEERED ANIMALS -- 6. SUMMARY -- GLOSSARY -- Suggested Reading -- Chapter 13 - The Use of Minipigs in Non-Clinical Research -- 1. INTRODUCTION -- 2. REGULATORY ASPECTS -- 3. MINIPIG STRAINS -- 4. ETHICS AND ANIMAL WELFARE -- 5. ANIMALS -- 6. PARAMETERS FOR EVALUATION IN SAFETY STUDIES PERFORMED IN SWINE -- 7. STUDIES -- 8. OTHER ROUTES OF DOSE ADMINISTRATION -- 9. SPONTANEOUS PATHOLOGY IN THE EXPERIMENTAL GÖTTINGEN MINIPIG -- 10. NEOPLASIA IN RESEARCH SWINE -- SUGGESTED READING -- Chapter 14 - Alternative Animal Models -- 1. INTRODUCTION -- 2. UTILIZATION OF ALTERNATIVE ANIMALS -- 3. ALTERNATIVE ANIMAL TAXA -- 4. SPECIAL CONSIDERATIONS -- 5. CONCLUSIONS -- Acknowledgments -- Suggested Reading.

Chapter 15 - Pathology and GLPs, Quality Control and Quality Assurance -- 1. INTRODUCTION -- 2. GOOD LABORATORY PRACTICE -- 3. GLP AND PATHOLOGY DATA -- 4. IN THE SPIRIT OF GLP -- 5. GLP CRITICISM -- SUGGESTED READING -- PART 3 - PRACTICE OF TOXICOLOGIC PATHOLOGY -- Chapter 16 - Nomenclature -- 1. BACKGROUND AND INTRODUCTION -- 2. THE NEED FOR STANDARDIZED NOMENCLATURE -- 3. COMPONENTS IN NOMENCLATURE -- 4. CHALLENGES IN STANDARDIZING NOMENCLATURE -- 5. SUGGESTED PRACTICES -- 6. HARMONIZATION OF NOMENCLATURE -- 7. SUMMARY -- Acknowledgments -- Suggested Reading -- Chapter 17 - Peer Review and Pathology Working Groups -- 1. INTRODUCTION -- 2. WHAT ARE THE QUALIFICATIONS OF THE PEER REVIEW PATHOLOGIST? -- 3. ARE PEER REVIEWS REQUIRED? -- 4. HOW IS A PEER REVIEW CONDUCTED? -- 5. PROSPECTIVE PEER REVIEWS -- 6. RETROSPECTIVE PEER REVIEW -- 7. PEER REVIEW STATEMENT -- 8. DOCUMENTATION OF THE PEER REVIEW AND DATA LOCKING -- 9. SOURCES OF DISAGREEMENT IN PEER REVIEWS -- 10. DIGITAL PEER REVIEWS -- 11. PATHOLOGY WORKING GROUP -- Suggested Reading -- Chapter 18 - Clinical Pathology in Non-Clinical Toxicology Testing -- 1. INTRODUCTION -- 2. PARAMETERS COMMONLY INCLUDED IN GENERAL TOXICOLOGY STUDY PROTOCOLS -- 3. ADDITIONAL AVAILABLE TESTS -- 4. NOVEL BIOMARKERS -- 5. CONCLUSIONS -- SUGGESTED READING -- Chapter 19 - Pathology Issues in the Design of Toxicology Studies -- 1. INTRODUCTION -- 2. DISCOVERY STUDIES -- 3. REGULATORY STUDIES -- 4. CARCINOGENICITY STUDIES -- 5. SPECIAL STUDIES: ANIMAL HEALTH PRODUCTS -- 6. SUMMARY AND CONCLUSIONS -- SUGGESTED READING -- Chapter 20 - Issues in Laboratory Animal Science -- 1. INTRODUCTION -- 2. RECENT TRENDS IN GLOBAL RESEARCH ANIMAL CARE AND USE -- 3. REGULATORY ISSUES -- 4. EUTHANASIA OF RESEARCH ANIMALS -- 5. SELECTION OF ANIMAL MODELS -- 6. ANIMAL HEALTH CONSIDERATIONS -- 7. HOUSING AND HUSBANDRY ISSUES.

8. THE ROLE OF DIET IN TOXICOLOGY STUDIES -- 9. 3RS FOR THE TOXICOLOGIC PATHOLOGIST -- 10. DESCRIPTION OF ANIMAL STUDIES IN SCIENTIFIC PUBLICATIONS -- 11. SUMMARY -- Suggested Reading -- e9780124157590v2 -- Front Cover -- Haschek and Rousseaux's Handbook of Toxicologic Pathology -- Copyright -- Contents -- Volume II - Safety Assessment Including Current and Emerging Issues in Toxicologic Pathology -- Safety Assessment in Toxicologic Pathology: An Introduction -- PART 1 - TOXICOLOGIC PATHOLOGY IN PRODUCT DISCOVERY AND SAFETY ASSESSMENT -- Chapter 21 - Overview of Drug Development -- 1. INTRODUCTION -- 2. OVERVIEW -- 3. DRUG DISCOVERY AND DEVELOPMENT -- 4. DEVELOPMENT -- 5. NON-CLINICAL STUDIES (SAFETY) -- 6. EFFICACY (E) -- 7. CLINICAL TRIALS -- 8. POST-MARKETING SURVEILLANCE -- 9. REGULATORY AUTHORITIES -- 10. SUMMARY AND CONCLUSIONS -- Suggested Reading -- Chapter 22 - Overview of the Role of Pathology in Product Discovery and Safety Assessment -- 1. INTRODUCTION -- 2. PATHOLOGISTS' CONTRIBUTIONS IN DRUG DISCOVERY -- 3. HISTORY OF PHARMACEUTICAL REGULATORY OVERSIGHT IN DRUG DEVELOPMENT -- 4. DESIGNING STUDIES TO ASSESS HUMAN RISK WITH TYPICAL DRUG CANDIDATES -- 5. DEVELOPMENT WITH BIOLOGICAL DRUG CANDIDATES -- 6. UNIQUE REQUIREMENTS FOR ANTICANCER DRUG CANDIDATES -- 7. OPTIMAL ANIMAL DOSE SELECTION ENHANCES CLINICAL STUDY DESIGN -- 8. PATHOLOGIST'S ROLE IN SPECIAL TOXICITY STUDIES -- Suggested Reading -- Chapter 23 - Discovery Toxicology and Pathology -- 1. INTRODUCTION -- 2. KNOWLEDGE INTEGRATION AND THE SPANNING OF DISCIPLINES -- 3. PATHOLOGY TOOLBOX -- 4. IN VITRO/IN VIVO CORRELATIONS -- 5. HYPOTHESIS GENERATION, EXPERIMENTAL DESIGN, AND THE ROLE OF INVESTIGATIVE STUDIES -- 6. TARGET VALIDATION AND IN VIVO RELEVANCE OF TARGET SELECTIVITY -- 7. DISCOVERY STRATEGY FOR BIOLOGICS -- 8. COMMUNICATIONS.

9. PERSONALITY AND BEHAVIORAL TRAITS THAT ARE HELPFUL TO SUCCEED IN DISCOVERY PATHOLOGY AND DISCOVERY TOXICOLOGY.