A Comprehensive Guide to Toxicology in Nonclinical Drug Development
eBook - ePub

A Comprehensive Guide to Toxicology in Nonclinical Drug Development

  1. 1,020 pages
  2. English
  3. ePUB (mobile friendly)
  4. Available on iOS & Android
eBook - ePub

A Comprehensive Guide to Toxicology in Nonclinical Drug Development

About this book

**Selected for 2026 Doody's Core Titles in Toxicology**A Comprehensive Guide to Toxicology in Nonclinical Drug Development, Third Edition is a valuable reference providing a complete understanding of all aspects of nonclinical toxicology in pharmaceutical research. This updated edition has been expanded and re-developed covering a wide-range of toxicological issues in small molecules and biologics. Topics include ADME in drug discovery, pharmacokinetics, toxicokinetics, formulations, and genetic toxicology testing. The book has been thoroughly updated throughout to reflect the latest scientific advances and includes new information on antiviral drugs, anti-diabetic drugs, immunotherapy, and a discussion on post-pandemic drug development challenges and opportunities. This is an essential and practical resource for all toxicologists involved in nonclinical testing in industry, academic, and regulatory settings. - Provides updated, unique content not covered in one comprehensive resource, including chapters on stem cells, antiviral drugs, anti-diabetic drugs, and immunotherapy - Includes the latest international guidelines for nonclinical toxicology in both small and large molecules - Incorporates practical examples in order to illustrate day-to-day activities and expectations associated with working in nonclinical toxicology

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Information

Publisher
Academic Press
Year
2024
Edition
3
eBook ISBN
9780323984621
Topic
Medicine
Subtopic
Pharmaceutical, Biotechnology & Healthcare Industry

Table of contents

  1. Cover
  2. Front Matter
  3. Table of Contents
  4. Copyright
  5. Dedication
  6. Contributors
  7. Preface
  8. List of Illustrations
  9. List of Tables
  10. Chapter 1 : Introduction to Drug Development
  11. Chapter 2 : Critical Aspects of Integrated Nonclinical Drug Development: Concepts, Strategies, and Potential Pitfalls
  12. Chapter 3 : Overview of ADME Science
  13. Chapter 4 : Pharmacokinetics and Toxicokinetics in Drug Development
  14. Chapter 5 : Development of Preclinical Formulations for Toxicology Studies
  15. Chapter 6 : Acute, Subacute, Subchronic, and Chronic General Toxicity Testing for Preclinical Drug Development
  16. Chapter 7 : Genetic Toxicology Testing
  17. Chapter 8 : The Preparation of a Preclinical Dossier to Support an Investigational New Drug Application and First-In-Human Clinical Trial
  18. Chapter 9 : Developmental and Reproductive Toxicology
  19. Chapter 10 : Immunotoxicology Assessment in Drug Development
  20. Chapter 11 : Juvenile Testing to Support Clinical Trials in Pediatric Population
  21. Chapter 12 : Preclinical Evaluation of Carcinogenicity Using Standard-Bred and Genetically Engineered Rodent Models
  22. Chapter 13 : Current Strategies for Abuse Liability Assessment of New Chemical Entities
  23. Chapter 14 : Clinical Pathology in Nonclinical Toxicity Studies
  24. Chapter 15 : Best Practice in Toxicologic Pathology
  25. Chapter 16 : Molecular Pathology: Applications in Nonclinical Drug Development
  26. Chapter 17 : Biomarkers in Nonclinical Drug Development
  27. Chapter 18 : Biostatistics for Toxicologists
  28. Chapter 19 : Regulatory Toxicology
  29. Chapter 20 : Study Directors and Study Monitors in Drug Development Safety Studies
  30. Chapter 21 : Infusion Toxicology and Techniques
  31. Chapter 22 : Photosafety Assessment
  32. Chapter 23 : Preclinical Development of Monoclonal Antibodies
  33. Chapter 24 : Preclinical Development of Antibody–Drug Conjugates
  34. Chapter 25 : Nonclinical Safety Assessment of Cell and Gene Therapies
  35. Chapter 26 : How Gene Editing Is Changing Drug Development
  36. Chapter 27 : Nonclinical Development of Oncology Drugs
  37. Chapter 28 : Preclinical Development of Nononcogenic Drugs (Small and Large Molecules)
  38. Chapter 29 : Overview of the Nonclinical Development Strategies and Class Effects of Oligonucleotide-based Therapeutics
  39. Chapter 30 : Animal Models for Infectious Disease Vaccine Development
  40. Chapter 31 : Preclinical Toxicology of Vaccines1
  41. Chapter 32 : Safety Evaluation of Ocular Drugs
  42. Chapter 33 : Nonclinical Safety Assessment of Botanical Products
  43. Chapter 34 : Biocompatibility Evaluation of Medical Devices
  44. Chapter 35 : Application of Evolving New Approach Methodologies for Chemical Safety Assessment
  45. Chapter 36 : Use of Imaging for Preclinical Evaluation
  46. Index
  47. A

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