| Description |
1 online resource (xvi, 885 pages) : illustrations |
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text file |
| Physical Medium |
polychrome |
| Note |
Title from pdf title page (viewed October 31, 2012). |
| Bibliography |
Includes bibliographical references and index. |
| Summary |
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 guidelines for safety evaluation and present both traditional and nontraditional toxicology models. By incorporating the latest research in this area and featuring real-life examples and scenarios, this reference is a complete and practical guide to all aspects of preclinical drug testing. Chapters written by world-renowned contributors who are experts in their fields. Includes the latest research in preclinical drug testing and international guidelines. Covers preclinical toxicology in small molecules and biologics in one single source. Incorporates real-life case studies and examples and offers readers a practical resource that outlines day-to-day activities and experiences in preclinical toxicology. |
| Contents |
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. |
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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. |
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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. |
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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. |
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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. |
| Local Note |
eBooks on EBSCOhost EBSCO eBook Subscription Academic Collection - North America |
| Subject |
Drugs -- Toxicology.
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Drugs -- Toxicology. |
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Drug development.
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Drug development. |
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Clinical toxicology.
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Clinical toxicology. |
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Drug Evaluation, Preclinical -- methods. |
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Drug Discovery. |
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Drug-Related Side Effects and Adverse Reactions -- prevention & control. |
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Toxicity Tests -- methods. |
| Genre/Form |
Electronic books.
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Electronic books.
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| Subject |
Medication. |
| Added Author |
Faqi, Ali S.
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| Other Form: |
Print version: Faqi, Ali S. A Comprehensive Guide to Toxicology in Preclinical Drug Development. Burlington : Elsevier Science, ©2012 9780123878151 |
| ISBN |
1283706504 |
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9781283706506 |
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9780123878151 (p-ISBN) |
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0123878152 (p-ISBN) |
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9780123878168 |
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0123878160 |
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