The Resource A comprehensive guide to toxicology in preclinical drug development, edited by Ali S. Faqi, (electronic resource/)

A comprehensive guide to toxicology in preclinical drug development, edited by Ali S. Faqi, (electronic resource/)

Label
A comprehensive guide to toxicology in preclinical drug development
Title
A comprehensive guide to toxicology in preclinical drug development
Statement of responsibility
edited by Ali S. Faqi
Contributor
Subject
Genre
Language
eng
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
Cataloging source
OPELS
Dewey number
615.1/9
Illustrations
illustrations
Index
index present
LC call number
RA1238
LC item number
.C66 2013
Literary form
non fiction
Nature of contents
  • dictionaries
  • bibliography
NLM call number
  • QV 600
  • QV 771
Label
A comprehensive guide to toxicology in preclinical drug development, edited by Ali S. Faqi, (electronic resource/)
Link
http://massasoit.idm.oclc.org/login?url=https://search.ebscohost.com/login.aspx?direct=true&authtype=cookie%2Cip%2Ccpid&custid=massas&scope=site&db=nlebk&AN=485040
Instantiates
Publication
Note
Title from pdf title page (viewed October 31, 2012)
Antecedent source
unknown
Bibliography note
Includes bibliographical references and index
Carrier category
online resource
Carrier category code
cr
Carrier MARC source
rdacarrier
Color
multicolored
Content category
text
Content type code
txt
Content type MARC source
rdacontent
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
Control code
ocn815520350
Dimensions
unknown
Extent
1 online resource (access may be restricted)
File format
unknown
Form of item
online
Governing access note
Access restricted to subscribing institution
Level of compression
unknown
Media category
computer
Media MARC source
rdamedia
Media type code
c
Quality assurance targets
not applicable
Reformatting quality
unknown
Sound
unknown sound
Specific material designation
remote
Label
A comprehensive guide to toxicology in preclinical drug development, edited by Ali S. Faqi, (electronic resource/)
Link
http://massasoit.idm.oclc.org/login?url=https://search.ebscohost.com/login.aspx?direct=true&authtype=cookie%2Cip%2Ccpid&custid=massas&scope=site&db=nlebk&AN=485040
Publication
Note
Title from pdf title page (viewed October 31, 2012)
Antecedent source
unknown
Bibliography note
Includes bibliographical references and index
Carrier category
online resource
Carrier category code
cr
Carrier MARC source
rdacarrier
Color
multicolored
Content category
text
Content type code
txt
Content type MARC source
rdacontent
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
Control code
ocn815520350
Dimensions
unknown
Extent
1 online resource (access may be restricted)
File format
unknown
Form of item
online
Governing access note
Access restricted to subscribing institution
Level of compression
unknown
Media category
computer
Media MARC source
rdamedia
Media type code
c
Quality assurance targets
not applicable
Reformatting quality
unknown
Sound
unknown sound
Specific material designation
remote

Library Locations

    • Massasoit Community College Brockton CampusBorrow it
      1 Massasoit Blvd., Brockton, MA, 02301, US
      42.07562679999999 -70.99027629999999
    • Nease Library - Eastern Nazarene College Borrow it
      23 East Elm Ave. , Quincy, MA, 02170, US
      42.271089 -71.012428
    • Quincy College Library Borrow it
      1250 Hancock St. 3rd Fl Rm#347, Quincy, MA, 02169, US
      42.2513682 -70.9962875
Processing Feedback ...