A comprehensive guide to toxicology in preclinical drug development / edited by Ali S. Faqi.

Format:

Book

Contributor:

Faqi, Ali S.

Language:

English

Subjects (All):

Drug development.

Physical Description:

1 online resource (903 p.)

Edition:

1st ed.

Place of Publication:

Amsterdam : Elsevier, 2013.

Language Note:

English

Summary:

A Comprehensive Guide to Toxicology in Preclinical Drug Development is a resource for toxicologists in industry and regulatory settings, as well as directors working in contract resource organizations, who need a thorough understanding of the drug development process. Incorporating real-life case studies and examples, the book is a practical guide that outlines day-to-day activities and experiences in preclinical toxicology. This multi-contributed reference provides a detailed picture of the complex and highly interrelated activities of preclinical toxicology in both small molecules

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

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

HISTOPATHOLOGY PROCESSES AND PROCEDURES

Notes:

Description based upon print version of record.

Includes bibliographical references and index.

ISBN:

1-283-70650-4

0-12-387816-0

OCLC:

818867493