A comprehensive guide to toxicology in preclinical drug development /

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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 toxic...

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Detalles Bibliográficos
Clasificación:Libro Electrónico
Otros Autores: Faqi, Ali S.
Formato: Electrónico eBook
Idioma:Inglés
Publicado: London ; Waltham, MA : Academic Press, 2013.
Temas:
Drugs > Toxicology.
Drug development.
Clinical toxicology.
Drugs > Side effects.
Drug-Related Side Effects and Adverse Reactions
Drug Discovery
Médicaments > Toxicologie.
Médicaments > Développement.
Toxicologie clinique.
Médicaments > Effets secondaires.
MEDICAL > Drug Guides.
MEDICAL > Nursing > Pharmacology.
MEDICAL > Pharmacology.
MEDICAL > Pharmacy.
Drugs > Side effects
Clinical toxicology
Drug development
Drugs > Toxicology
Acceso en línea:Texto completo
Tabla de Contenidos:
  • 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.

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