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.
1. Chapter 1 : Introduction to Drug Development - p. Page ix 2. Chapter 2 : Critical Aspects of Integrated Nonclinical Drug Development: Concepts, Strategies, and Potential Pitfalls - p. Page 7 3. Chapter 3 : Overview of ADME Science - p. Page 42 4. Chapter 4 : Pharmacokinetics and Toxicokinetics in Drug Development - p. Page 78 5. Chapter 5 : Development of Preclinical Formulations for Toxicology Studies - p. Page 120 6. Chapter 6 : Acute, Subacute, Subchronic, and Chronic General Toxicity Testing for Preclinical Drug Development - p. Page 145 7. Chapter 7 : Genetic Toxicology Testing - p. Page 170 8. Chapter 8 : The Preparation of a Preclinical Dossier to Support an Investigational New Drug Application and First-In-Human Clinical Trial - p. Page 193 9. Chapter 9 : Developmental and Reproductive Toxicology - p. Page 224 10. Chapter 10 : Immunotoxicology Assessment in Drug Development - p. Page 254 11. Chapter 11 : Juvenile Testing to Support Clinical Trials in Pediatric Population - p. Page 269 12. Chapter 12 : Preclinical Evaluation of Carcinogenicity Using Standard-Bred and Genetically Engineered Rodent Models - p. Page 283 13. Chapter 13 : Current Strategies for Abuse Liability Assessment of New Chemical Entities - p. Page 303 14. Chapter 14 : Clinical Pathology in Nonclinical Toxicity Studies - p. Page 335 15. Chapter 15 : Best Practice in Toxicologic Pathology - p. Page 383 16. Chapter 16 : Molecular Pathology: Applications in Nonclinical Drug Development - p. Page 421 17. Chapter 17 : Biomarkers in Nonclinical Drug Development - p. Page 456 18. Chapter 18 : Biostatistics for Toxicologists - p. Page 484 19. Chapter 19 : Regulatory Toxicology - p. Page 513 20. Chapter 20 : Study Directors and Study Monitors in Drug Development Safety Studies - p. Page 555 21. Chapter 21 : Infusion Toxicology and Techniques - p. Page 570 22. Chapter 22 : Photosafety Assessment - p. Page 599 23. Chapter 23 : Preclinical Development of Monoclonal Antibodies - p. Page 630 24. Chapter 24 : Preclinical Development of Antibody–Drug Conjugates - p. Page 667 25. Chapter 25 : Nonclinical Safety Assessment of Cell and Gene Therapies - p. Page 689 26. Chapter 26 : How Gene Editing Is Changing Drug Development - p. Page 706 27. Chapter 27 : Nonclinical Development of Oncology Drugs - p. Page 714 28. Chapter 28 : Preclinical Development of Nononcogenic Drugs (Small and Large Molecules) - p. Page 740 29. Chapter 29 : Overview of the Nonclinical Development Strategies and Class Effects of Oligonucleotide-based Therapeutics - p. Page 767 30. Chapter 30 : Animal Models for Infectious Disease Vaccine Development - p. Page 786 31. Chapter 31 : Preclinical Toxicology of Vaccines1 - p. Page 824 32. Chapter 32 : Safety Evaluation of Ocular Drugs - p. Page 871 33. Chapter 33 : Nonclinical Safety Assessment of Botanical Products - p. Page 934 34. Chapter 34 : Biocompatibility Evaluation of Medical Devices - p. Page 955 35. Chapter 35 : Application of Evolving New Approach Methodologies for Chemical Safety Assessment - p. Page 972 36. Chapter 36 : Use of Imaging for Preclinical Evaluation - p. Page 1009 37. Index - p. Page 1027
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.
1. Chapter 1 : Introduction to Drug Development - p. Page ix 2. Chapter 2 : Critical Aspects of Integrated Nonclinical Drug Development: Concepts, Strategies, and Potential Pitfalls - p. Page 7 3. Chapter 3 : Overview of ADME Science - p. Page 42 4. Chapter 4 : Pharmacokinetics and Toxicokinetics in Drug Development - p. Page 78 5. Chapter 5 : Development of Preclinical Formulations for Toxicology Studies - p. Page 120 6. Chapter 6 : Acute, Subacute, Subchronic, and Chronic General Toxicity Testing for Preclinical Drug Development - p. Page 145 7. Chapter 7 : Genetic Toxicology Testing - p. Page 170 8. Chapter 8 : The Preparation of a Preclinical Dossier to Support an Investigational New Drug Application and First-In-Human Clinical Trial - p. Page 193 9. Chapter 9 : Developmental and Reproductive Toxicology - p. Page 224 10. Chapter 10 : Immunotoxicology Assessment in Drug Development - p. Page 254 11. Chapter 11 : Juvenile Testing to Support Clinical Trials in Pediatric Population - p. Page 269 12. Chapter 12 : Preclinical Evaluation of Carcinogenicity Using Standard-Bred and Genetically Engineered Rodent Models - p. Page 283 13. Chapter 13 : Current Strategies for Abuse Liability Assessment of New Chemical Entities - p. Page 303 14. Chapter 14 : Clinical Pathology in Nonclinical Toxicity Studies - p. Page 335 15. Chapter 15 : Best Practice in Toxicologic Pathology - p. Page 383 16. Chapter 16 : Molecular Pathology: Applications in Nonclinical Drug Development - p. Page 421 17. Chapter 17 : Biomarkers in Nonclinical Drug Development - p. Page 456 18. Chapter 18 : Biostatistics for Toxicologists - p. Page 484 19. Chapter 19 : Regulatory Toxicology - p. Page 513 20. Chapter 20 : Study Directors and Study Monitors in Drug Development Safety Studies - p. Page 555 21. Chapter 21 : Infusion Toxicology and Techniques - p. Page 570 22. Chapter 22 : Photosafety Assessment - p. Page 599 23. Chapter 23 : Preclinical Development of Monoclonal Antibodies - p. Page 630 24. Chapter 24 : Preclinical Development of Antibody–Drug Conjugates - p. Page 667 25. Chapter 25 : Nonclinical Safety Assessment of Cell and Gene Therapies - p. Page 689 26. Chapter 26 : How Gene Editing Is Changing Drug Development - p. Page 706 27. Chapter 27 : Nonclinical Development of Oncology Drugs - p. Page 714 28. Chapter 28 : Preclinical Development of Nononcogenic Drugs (Small and Large Molecules) - p. Page 740 29. Chapter 29 : Overview of the Nonclinical Development Strategies and Class Effects of Oligonucleotide-based Therapeutics - p. Page 767 30. Chapter 30 : Animal Models for Infectious Disease Vaccine Development - p. Page 786 31. Chapter 31 : Preclinical Toxicology of Vaccines1 - p. Page 824 32. Chapter 32 : Safety Evaluation of Ocular Drugs - p. Page 871 33. Chapter 33 : Nonclinical Safety Assessment of Botanical Products - p. Page 934 34. Chapter 34 : Biocompatibility Evaluation of Medical Devices - p. Page 955 35. Chapter 35 : Application of Evolving New Approach Methodologies for Chemical Safety Assessment - p. Page 972 36. Chapter 36 : Use of Imaging for Preclinical Evaluation - p. Page 1009 37. Index - p. Page 1027
