A comprehensive guide to toxicology in preclinical drug development:
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| Format: | Electronic eBook |
|---|---|
| Language: | English |
| Published: |
Amsterdam
Elsevier
2013
|
| Edition: | 1st ed |
| Subjects: | |
| Online Access: | FAW01 FAW02 |
| Item Description: | Includes bibliographical references and index Front Cover; A Comprehensive Guide to Toxicology in Preclinical Drug Development; Copyright; Dedication; Contents; Foreword; Contributors; Chapter1 -- Introduction; Chapter2 -- ADME in Drug Discovery; INTRODUCTION; ADME; USE OF PRECLINICAL ADME DATA; TWO EVOLVING TECHNOLOGIES IMPACTING ADME IN DRUG DISCOVERY; References; Chapter3 -- Pharmacokinetics and Toxicokinetics; INTRODUCTION; DRUG ADMINISTRATION AND DELIVERY; INTRAVENOUS ADMINISTRATION; ABSORPTION AFTER EXTRAVASCULAR DOSING; CALCULATION OF EXPOSURE-BASED SAFETY MARGINS; PRACTICAL CONSIDERATIONS; CONCLUSIONS; References Chapter4 -- Development of Preclinical Formulations for Toxicology StudiesINTRODUCTION; ANIMAL SPECIES, SAMPLING VOLUMES AND SAMPLING SITES; DOSING ROUTE; DOSING VOLUME; FORMULATION DEVELOPMENT; PHYSICO-CHEMICAL PROPERTY CHARACTERIZATION; SOLUBILITY ENHANCEMENT; SPECIAL DOSAGE FORMS; DECISION TREE; IN VITRO EVALUATION OF THE PERFORMANCE OF A TOXICOLOGICAL STUDY; CASE STUDY; CONCLUDING REMARKS; References; Chapter5 -- Acute, Sub-Acute, Sub-Chronic and Chronic General Toxicity Testing for Preclinical Drug Development; INTRODUCTION. REGULATORY CONSIDERATIONS FOR CONDUCTING PRECLINICAL TOXICOLOGY STUDIESGENERAL CONSIDERATIONS FOR THE CONDUCT OF PRECLINICAL TOXICOLOGY STUDIES; STUDY TYPES USED IN THE ASSESSMENT OF GENERAL TOXICOLOGY; SPECIAL CONSIDERATIONS FOR BIOPHARMACEUTICAL SAFETY EVALUATIONS; COMMON PROTOCOL COMPONENTS OF GENERAL TOXICITY ASSESSMENTS IN GLP STUDIES; FINAL THOUGHTS; References; Chapter6 -- Contemporary Practices in Core Safety Pharmacology Assessments; BACKGROUND AND OVERVIEW; SAFETY PHARMACOLOGY AS A REGULATORY SCIENCE; TEMPORAL APPLICATION OF CURRENT EXPERIMENTAL PARADIGMS. CARDIOVASCULAR SYSTEM AND MODELS OF SAFETY ASSESSMENTCARDIAC ION CHANNELS AND THE HERG ASSAY; IN VIVO CARDIOVASCULAR SAFETY STUDY; RESPIRATORY SYSTEM AND MODELS OF SAFETY ASSESSMENT; CENTRAL NERVOUS SYSTEM AND MODELS OF SAFETY ASSESSMENT; APPROACHES TO TIER I CNS SAFETY EVALUATION; EVALUATING CNS SAFETY; References; Chapter7 -- Genetic Toxicology Testing; INTRODUCTION; THE CONCEPT OF THRESHOLDS; GENETIC TOXICITY TESTING TO SUPPORT CLINICAL TRIALS; THE SENSITIVITY AND SPECIFICITY OF IN VITRO ASSAYS; IN VIVO CORE TESTS; OTHER IN VIVO TESTS FOR GENOTOXICITY. ADDITIONAL TESTS INDICATING GENOTOXICITYGENETOX TESTING STRATEGY: DISCOVERY THROUGH DEVELOPMENT; CONCLUDING REMARKS AND FUTURE DIRECTIONS; References; Chapter8 -- Clinical Pathology; INTRODUCTION; CORE CLINICAL PATHOLOGY TESTING; HEMATOLOGY; CYTOLOGICAL EVALUATION OF BONE MARROW; EMERGING BIOMARKERS AND APPLICATION WITHIN THE CLINICAL PATHOLOGY LABORATORY; CLINICAL PATHOLOGY INDICATORS OF TARGET ORGAN TOXICITY; INTERPRETATION OF CLINICAL PATHOLOGY DATA IN PRECLINICAL SAFETY STUDIES; References; Chapter9 -- Best Practice in Toxicological Pathology; INTRODUCTION. A Comprehensive Guide to Toxicology in Preclinical Drug Development is designed for toxicologists who need a thorough understanding of the drug development process. This multi-contributed reference will provide a detailed picture of the complex and highly interrelated activities of preclinical toxicology in both small molecules and biologics. Intended as a comprehensive resource for toxicologists in industry and regulatory settings, as well as directors working in contract resource organizations (CRO), this book will discuss discovery toxicology and the international guideline |
| Physical Description: | xvi, 885 pages |
| ISBN: | 9780123878168 0123878160 9780123878151 |
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| 245 | 1 | 0 | |a A comprehensive guide to toxicology in preclinical drug development |c edited by Ali S. Faqi |
| 250 | |a 1st ed | ||
| 264 | 1 | |a Amsterdam |b Elsevier |c 2013 | |
| 300 | |a xvi, 885 pages | ||
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| 500 | |a Includes bibliographical references and index | ||
| 500 | |a Front Cover; A Comprehensive Guide to Toxicology in Preclinical Drug Development; Copyright; Dedication; Contents; Foreword; Contributors; Chapter1 -- Introduction; Chapter2 -- ADME in Drug Discovery; INTRODUCTION; ADME; USE OF PRECLINICAL ADME DATA; TWO EVOLVING TECHNOLOGIES IMPACTING ADME IN DRUG DISCOVERY; References; Chapter3 -- Pharmacokinetics and Toxicokinetics; INTRODUCTION; DRUG ADMINISTRATION AND DELIVERY; INTRAVENOUS ADMINISTRATION; ABSORPTION AFTER EXTRAVASCULAR DOSING; CALCULATION OF EXPOSURE-BASED SAFETY MARGINS; PRACTICAL CONSIDERATIONS; CONCLUSIONS; References | ||
| 500 | |a Chapter4 -- Development of Preclinical Formulations for Toxicology StudiesINTRODUCTION; ANIMAL SPECIES, SAMPLING VOLUMES AND SAMPLING SITES; DOSING ROUTE; DOSING VOLUME; FORMULATION DEVELOPMENT; PHYSICO-CHEMICAL PROPERTY CHARACTERIZATION; SOLUBILITY ENHANCEMENT; SPECIAL DOSAGE FORMS; DECISION TREE; IN VITRO EVALUATION OF THE PERFORMANCE OF A TOXICOLOGICAL STUDY; CASE STUDY; CONCLUDING REMARKS; References; Chapter5 -- Acute, Sub-Acute, Sub-Chronic and Chronic General Toxicity Testing for Preclinical Drug Development; INTRODUCTION. | ||
| 500 | |a REGULATORY CONSIDERATIONS FOR CONDUCTING PRECLINICAL TOXICOLOGY STUDIESGENERAL CONSIDERATIONS FOR THE CONDUCT OF PRECLINICAL TOXICOLOGY STUDIES; STUDY TYPES USED IN THE ASSESSMENT OF GENERAL TOXICOLOGY; SPECIAL CONSIDERATIONS FOR BIOPHARMACEUTICAL SAFETY EVALUATIONS; COMMON PROTOCOL COMPONENTS OF GENERAL TOXICITY ASSESSMENTS IN GLP STUDIES; FINAL THOUGHTS; References; Chapter6 -- Contemporary Practices in Core Safety Pharmacology Assessments; BACKGROUND AND OVERVIEW; SAFETY PHARMACOLOGY AS A REGULATORY SCIENCE; TEMPORAL APPLICATION OF CURRENT EXPERIMENTAL PARADIGMS. | ||
| 500 | |a CARDIOVASCULAR SYSTEM AND MODELS OF SAFETY ASSESSMENTCARDIAC ION CHANNELS AND THE HERG ASSAY; IN VIVO CARDIOVASCULAR SAFETY STUDY; RESPIRATORY SYSTEM AND MODELS OF SAFETY ASSESSMENT; CENTRAL NERVOUS SYSTEM AND MODELS OF SAFETY ASSESSMENT; APPROACHES TO TIER I CNS SAFETY EVALUATION; EVALUATING CNS SAFETY; References; Chapter7 -- Genetic Toxicology Testing; INTRODUCTION; THE CONCEPT OF THRESHOLDS; GENETIC TOXICITY TESTING TO SUPPORT CLINICAL TRIALS; THE SENSITIVITY AND SPECIFICITY OF IN VITRO ASSAYS; IN VIVO CORE TESTS; OTHER IN VIVO TESTS FOR GENOTOXICITY. | ||
| 500 | |a ADDITIONAL TESTS INDICATING GENOTOXICITYGENETOX TESTING STRATEGY: DISCOVERY THROUGH DEVELOPMENT; CONCLUDING REMARKS AND FUTURE DIRECTIONS; References; Chapter8 -- Clinical Pathology; INTRODUCTION; CORE CLINICAL PATHOLOGY TESTING; HEMATOLOGY; CYTOLOGICAL EVALUATION OF BONE MARROW; EMERGING BIOMARKERS AND APPLICATION WITHIN THE CLINICAL PATHOLOGY LABORATORY; CLINICAL PATHOLOGY INDICATORS OF TARGET ORGAN TOXICITY; INTERPRETATION OF CLINICAL PATHOLOGY DATA IN PRECLINICAL SAFETY STUDIES; References; Chapter9 -- Best Practice in Toxicological Pathology; INTRODUCTION. | ||
| 500 | |a A Comprehensive Guide to Toxicology in Preclinical Drug Development is designed for toxicologists who need a thorough understanding of the drug development process. This multi-contributed reference will provide a detailed picture of the complex and highly interrelated activities of preclinical toxicology in both small molecules and biologics. Intended as a comprehensive resource for toxicologists in industry and regulatory settings, as well as directors working in contract resource organizations (CRO), this book will discuss discovery toxicology and the international guideline | ||
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| 650 | 4 | |a Toxicology | |
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| 700 | 1 | |a Faqi, Ali S. |e Sonstige |4 oth | |
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| illustrated | Not Illustrated |
| indexdate | 2024-07-10T07:39:47Z |
| institution | BVB |
| isbn | 9780123878168 0123878160 9780123878151 |
| language | English |
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| physical | xvi, 885 pages |
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| spelling | A comprehensive guide to toxicology in preclinical drug development edited by Ali S. Faqi 1st ed Amsterdam Elsevier 2013 xvi, 885 pages txt rdacontent c rdamedia cr rdacarrier Includes bibliographical references and index Front Cover; A Comprehensive Guide to Toxicology in Preclinical Drug Development; Copyright; Dedication; Contents; Foreword; Contributors; Chapter1 -- Introduction; Chapter2 -- ADME in Drug Discovery; INTRODUCTION; ADME; USE OF PRECLINICAL ADME DATA; TWO EVOLVING TECHNOLOGIES IMPACTING ADME IN DRUG DISCOVERY; References; Chapter3 -- Pharmacokinetics and Toxicokinetics; INTRODUCTION; DRUG ADMINISTRATION AND DELIVERY; INTRAVENOUS ADMINISTRATION; ABSORPTION AFTER EXTRAVASCULAR DOSING; CALCULATION OF EXPOSURE-BASED SAFETY MARGINS; PRACTICAL CONSIDERATIONS; CONCLUSIONS; References Chapter4 -- Development of Preclinical Formulations for Toxicology StudiesINTRODUCTION; ANIMAL SPECIES, SAMPLING VOLUMES AND SAMPLING SITES; DOSING ROUTE; DOSING VOLUME; FORMULATION DEVELOPMENT; PHYSICO-CHEMICAL PROPERTY CHARACTERIZATION; SOLUBILITY ENHANCEMENT; SPECIAL DOSAGE FORMS; DECISION TREE; IN VITRO EVALUATION OF THE PERFORMANCE OF A TOXICOLOGICAL STUDY; CASE STUDY; CONCLUDING REMARKS; References; Chapter5 -- Acute, Sub-Acute, Sub-Chronic and Chronic General Toxicity Testing for Preclinical Drug Development; INTRODUCTION. REGULATORY CONSIDERATIONS FOR CONDUCTING PRECLINICAL TOXICOLOGY STUDIESGENERAL CONSIDERATIONS FOR THE CONDUCT OF PRECLINICAL TOXICOLOGY STUDIES; STUDY TYPES USED IN THE ASSESSMENT OF GENERAL TOXICOLOGY; SPECIAL CONSIDERATIONS FOR BIOPHARMACEUTICAL SAFETY EVALUATIONS; COMMON PROTOCOL COMPONENTS OF GENERAL TOXICITY ASSESSMENTS IN GLP STUDIES; FINAL THOUGHTS; References; Chapter6 -- Contemporary Practices in Core Safety Pharmacology Assessments; BACKGROUND AND OVERVIEW; SAFETY PHARMACOLOGY AS A REGULATORY SCIENCE; TEMPORAL APPLICATION OF CURRENT EXPERIMENTAL PARADIGMS. CARDIOVASCULAR SYSTEM AND MODELS OF SAFETY ASSESSMENTCARDIAC ION CHANNELS AND THE HERG ASSAY; IN VIVO CARDIOVASCULAR SAFETY STUDY; RESPIRATORY SYSTEM AND MODELS OF SAFETY ASSESSMENT; CENTRAL NERVOUS SYSTEM AND MODELS OF SAFETY ASSESSMENT; APPROACHES TO TIER I CNS SAFETY EVALUATION; EVALUATING CNS SAFETY; References; Chapter7 -- Genetic Toxicology Testing; INTRODUCTION; THE CONCEPT OF THRESHOLDS; GENETIC TOXICITY TESTING TO SUPPORT CLINICAL TRIALS; THE SENSITIVITY AND SPECIFICITY OF IN VITRO ASSAYS; IN VIVO CORE TESTS; OTHER IN VIVO TESTS FOR GENOTOXICITY. ADDITIONAL TESTS INDICATING GENOTOXICITYGENETOX TESTING STRATEGY: DISCOVERY THROUGH DEVELOPMENT; CONCLUDING REMARKS AND FUTURE DIRECTIONS; References; Chapter8 -- Clinical Pathology; INTRODUCTION; CORE CLINICAL PATHOLOGY TESTING; HEMATOLOGY; CYTOLOGICAL EVALUATION OF BONE MARROW; EMERGING BIOMARKERS AND APPLICATION WITHIN THE CLINICAL PATHOLOGY LABORATORY; CLINICAL PATHOLOGY INDICATORS OF TARGET ORGAN TOXICITY; INTERPRETATION OF CLINICAL PATHOLOGY DATA IN PRECLINICAL SAFETY STUDIES; References; Chapter9 -- Best Practice in Toxicological Pathology; INTRODUCTION. A Comprehensive Guide to Toxicology in Preclinical Drug Development is designed for toxicologists who need a thorough understanding of the drug development process. This multi-contributed reference will provide a detailed picture of the complex and highly interrelated activities of preclinical toxicology in both small molecules and biologics. Intended as a comprehensive resource for toxicologists in industry and regulatory settings, as well as directors working in contract resource organizations (CRO), this book will discuss discovery toxicology and the international guideline MEDICAL / Drug Guides bisacsh MEDICAL / Nursing / Pharmacology bisacsh MEDICAL / Pharmacology bisacsh MEDICAL / Pharmacy bisacsh Drug development fast Toxicology Medizin Drug development Faqi, Ali S. Sonstige oth |
| spellingShingle | A comprehensive guide to toxicology in preclinical drug development MEDICAL / Drug Guides bisacsh MEDICAL / Nursing / Pharmacology bisacsh MEDICAL / Pharmacology bisacsh MEDICAL / Pharmacy bisacsh Drug development fast Toxicology Medizin Drug development |
| title | A comprehensive guide to toxicology in preclinical drug development |
| title_auth | A comprehensive guide to toxicology in preclinical drug development |
| title_exact_search | A comprehensive guide to toxicology in preclinical drug development |
| title_full | A comprehensive guide to toxicology in preclinical drug development edited by Ali S. Faqi |
| title_fullStr | A comprehensive guide to toxicology in preclinical drug development edited by Ali S. Faqi |
| title_full_unstemmed | A comprehensive guide to toxicology in preclinical drug development edited by Ali S. Faqi |
| title_short | A comprehensive guide to toxicology in preclinical drug development |
| title_sort | a comprehensive guide to toxicology in preclinical drug development |
| topic | MEDICAL / Drug Guides bisacsh MEDICAL / Nursing / Pharmacology bisacsh MEDICAL / Pharmacology bisacsh MEDICAL / Pharmacy bisacsh Drug development fast Toxicology Medizin Drug development |
| topic_facet | MEDICAL / Drug Guides MEDICAL / Nursing / Pharmacology MEDICAL / Pharmacology MEDICAL / Pharmacy Drug development Toxicology Medizin |
| work_keys_str_mv | AT faqialis acomprehensiveguidetotoxicologyinpreclinicaldrugdevelopment |