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A comprehensive guide to toxicology in nonclinical drug development / edited by Ali Said Faqi,

Contributor(s): Material type: TextTextPublisher: Amsterdam : Academic Press is an imprint of Elsevier, [2017]Copyright date: ©2017Edition: Second editionDescription: xiii, 971 pages : illustrations (some color), portraits ; 29 cmContent type:
  • text
Media type:
  • unmediated
Carrier type:
  • volume
ISBN:
  • 9780128036204 (hbk.)
  • 0128036206 (hbk.)
ISSN:
  • 9780128036204
Uniform titles:
  • Comprehensive guide to toxicology in preclinical drug development.
Subject(s): LOC classification:
  • RA1238 .COM 2017
Contents:
1. Introduction; 2. ADME in Drug Discovery; 3. Pharmacokinetics and Toxicokinetics; 4. Acute, Sub-Acute, Sub-Chronic and Chronic, Dermal and Inhalation Toxicology; 5. Contemporary Practices in Core Safety Pharmacology Assessments; 6. Genetic Toxicology Testing; 7. Clinical Pathology; 8. Best Practice in Toxicologic Pathology; 9. Molecular Pathology: Applications in Nonclinical Drug Development; 10. Infusion Toxicology and Techniques; 11. The Preparation of a Nonclinical Dossier to Support an Investigational New Drug (IND) Application and First-in-Human Clinical Trials; 12. Developmental and Reproductive Toxicology; 13. Immunotoxicology Assessment in Drug Development; 14. Juvenile Toxicity Testing to Support Clinical Trials in the Pediatric Population; 15. Photosafety: Current Methods and Future Direction; 16. Dermal Toxicology; 17. Inhalation Toxicology; 18. Nonclinical Evaluation of Carcinogenicity using the Rodent Two-Year Bioassay and Carcinogenicity Evaluations using Genetically Engineered Animals; 19 Current Strategies for Abuse Liability Assessment of New Chemical Entities; 20. Nonclinical Development of Monoclonal Antibodies; 21. Nonclinical Development of Non-Oncogenic Drugs (Small and Large Molecules); 22. Nonclinical Development of Oncology Drugs; 23. Safety Evaluation of Ocular Drugs; 24. Nonclinical toxicology of Vaccines; 25. Stem Cells In Nonclinical Toxicology; 26. Overview of the Nonclinical Development Strategies and Class-Effects of Oligonucleotide-Based Therapeutics; 27. Nonclinical Safety Assessment of Botanical Drugs; 28. Regulatory Toxicology; 29. Biostatistics for Toxicologists; 30. Role of Study Director and Study Monitor in Drug Development; 31. Use of Imaging for Nonclinical Evaluation; 32. Biomarkers in Toxicology; 33. Predictive Toxicology: Biological Assay Platforms; 34. Toxicometabolomics: Technology and Applications; 35. Toxicogenomics in Nonclinical Development; 36. Nonclinical Testing of Medical Devices; 37. The Pitfalls of Drug Development
Summary: This book is designed to provide a complete understanding of all aspects of nonclinical toxicology in the development of small molecules and biologics. This updated edition has been reorganized and expanded to include important topics such as stem cells in nonclinical toxicology, inhalation and dermal toxicology, pitfalls in drug development, biomarkers in toxicology, and more
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Holdings
Item type Current library Home library Collection Call number Copy number Status Date due Barcode Item holds
Books Books Medical Library General Stacks Medical Library Non-fiction RA1238 COM 2017 (Browse shelf(Opens below)) c. 1 Available 032639
Total holds: 0

Preceded by Comprehensive guide to toxicology in preclinical drug development / edited by Ali S. Faqi. 1st ed. 2013.

Includes bibliographical references and index.

1. Introduction; 2. ADME in Drug Discovery; 3. Pharmacokinetics and Toxicokinetics; 4. Acute, Sub-Acute, Sub-Chronic and Chronic, Dermal and Inhalation Toxicology; 5. Contemporary Practices in Core Safety Pharmacology Assessments; 6. Genetic Toxicology Testing; 7. Clinical Pathology; 8. Best Practice in Toxicologic Pathology; 9. Molecular Pathology: Applications in Nonclinical Drug Development; 10. Infusion Toxicology and Techniques; 11. The Preparation of a Nonclinical Dossier to Support an Investigational New Drug (IND) Application and First-in-Human Clinical Trials; 12. Developmental and Reproductive Toxicology; 13. Immunotoxicology Assessment in Drug Development; 14. Juvenile Toxicity Testing to Support Clinical Trials in the Pediatric Population; 15. Photosafety: Current Methods and Future Direction; 16. Dermal Toxicology; 17. Inhalation Toxicology; 18. Nonclinical Evaluation of Carcinogenicity using the Rodent Two-Year Bioassay and Carcinogenicity Evaluations using Genetically Engineered Animals; 19 Current Strategies for Abuse Liability Assessment of New Chemical Entities; 20. Nonclinical Development of Monoclonal Antibodies; 21. Nonclinical Development of Non-Oncogenic Drugs (Small and Large Molecules); 22. Nonclinical Development of Oncology Drugs; 23. Safety Evaluation of Ocular Drugs; 24. Nonclinical toxicology of Vaccines; 25. Stem Cells In Nonclinical Toxicology; 26. Overview of the Nonclinical Development Strategies and Class-Effects of Oligonucleotide-Based Therapeutics; 27. Nonclinical Safety Assessment of Botanical Drugs; 28. Regulatory Toxicology; 29. Biostatistics for Toxicologists; 30. Role of Study Director and Study Monitor in Drug Development; 31. Use of Imaging for Nonclinical Evaluation; 32. Biomarkers in Toxicology; 33. Predictive Toxicology: Biological Assay Platforms; 34. Toxicometabolomics: Technology and Applications; 35. Toxicogenomics in Nonclinical Development; 36. Nonclinical Testing of Medical Devices; 37. The Pitfalls of Drug Development

This book is designed to provide a complete understanding of all aspects of nonclinical toxicology in the development of small molecules and biologics. This updated edition has been reorganized and expanded to include important topics such as stem cells in nonclinical toxicology, inhalation and dermal toxicology, pitfalls in drug development, biomarkers in toxicology, and more

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