1. Introduction<br><br>Section I. Drug Discovery, Metabolism, and Pharmacokinetics<br>2. Critical Aspects of Integrated Nonclinical Drug Development: Concepts, Strategies, and Potential Pitfalls<br>3. ADME in Drug Discovery<br>4. Pharmacokinetics and Toxicokinetics<br>5. Secondary Pharmacology Screening in Drug Discovery<br><br>Section II. Toxicological Studies and Ind Application, and First In-Human Clinical Trial<br>6. Acute, Subacute, Subchronic, and Chronic General Toxicity Testing for Preclinical Drug Development<br>7. Genetic Toxicology Testing<br>8. Contemporary Practices in Core Safety Pharmacology Assessments<br>9. Preparation of a Preclinical Dossier to Support an Investigational New Drug (IND) Application and First-In-Human Clinical Trial<br>10. Developmental and Reproductive Toxicology<br>11. Juvenile Testing to Support Clinical Trials in Pediatric Population<br>12. Preclinical Evaluation of Carcinogenicity Using Standard-Bred and Genetically Engineered Rodent Models<br>13. Current Strategies for Abuse Liability Assessment of New Chemical Entities<br><br>Section III. Clinical Pathology, Histopathology, and Biomarkers<br>14. Clinical Pathology<br>15. Best Practice in Toxicological Pathology<br>16. Molecular Pathology: Applications in Nonclinical Drug Development<br>17. Biomarkers in Nonclinical Drug Development<br>IV. Biostatistics, Regulatory Toxicology, and Role of Study Directors<br>18. Biostatistics for Toxicologists<br>19. Regulatory Toxicology<br>20. Role of Study Director and Study Monitor in Drug Development Safety Studies<br><br>Section V. Specialty Route of Administration<br>21. Infusion Toxicology and Techniques<br>22. Photosafety Assessment<br><br>Section VI. Nonclinical Development of Monoclonal Antibodies, Stem Cells, Oncogenic and Non-Oncogenic Drugs, Oligonucleotides, and Vaccines<br>23. Preclinical Development of Monoclonal Antibodies<br>24. Nonclinical Safety Assessment of Cell-Based Therapies<br>25. Nonclinical Development of Antiviral Drugs<br>26. Nonclinical Assessment of Anti-diabetic drugs<br>27. Safety Assessments of Cancer Immunotherapy Drugs<br>28. Application of Micro-physiological systems to enhance drug safety assessment<br>29. Use of Humanized mice in Safety Assessment<br>30. Safety Assessment of Cell and Gene Therapy<br>31. Preclinical Development of Oncology Drugs<br>32. Preclinical Toxicology of Vaccines<br>33. Overview of the Nonclinical Development Strategies and Class-Effects of Oligonucleotide-Based Therapeutics<br><br>Section VII. Safety Evaluation of Ocular Drugs, Botanical Products, and Medicinal Devices<br>34. Safety Evaluation of Ocular Drugs<br>35. Safety Assessment of Targeted Protein Degraders (TBD)<br>36. Biocompatibility Evaluation of Medical Devices<br><br>Section VIII. Predictive Toxicology, Toxicometabolomics, Toxicogenomics, and Imaging<br>37. Application of Evolving Computational and Biological Platforms for Chemical Safety Assessment<br>38. Use of Imaging for Preclinical Evaluation<br>39. Drug Development Challenges and Opportunities Post-Pandemic
