A Comprehensive Guide to Toxicology in Nonclinical Drug Development

ISBN-13: 9780323857048 / Twarda / 2024 / 1020 str.

Spis treści

1. Introduction

Section I. Drug Discovery, Metabolism, and Pharmacokinetics
2. Critical Aspects of Integrated Nonclinical Drug Development: Concepts, Strategies, and Potential Pitfalls
3. ADME in Drug Discovery
4. Pharmacokinetics and Toxicokinetics
5. Secondary Pharmacology Screening in Drug Discovery

Section II. Toxicological Studies and Ind Application, and First In-Human Clinical Trial
6. Acute, Subacute, Subchronic, and Chronic General Toxicity Testing for Preclinical Drug Development
7. Genetic Toxicology Testing
8. Contemporary Practices in Core Safety Pharmacology Assessments
9. Preparation of a Preclinical Dossier to Support an Investigational New Drug (IND) Application and First-In-Human Clinical Trial
10. Developmental and Reproductive Toxicology
11. Juvenile Testing to Support Clinical Trials in Pediatric Population
12. Preclinical Evaluation of Carcinogenicity Using Standard-Bred and Genetically Engineered Rodent Models
13. Current Strategies for Abuse Liability Assessment of New Chemical Entities

Section III. Clinical Pathology, Histopathology, and Biomarkers
14. Clinical Pathology
15. Best Practice in Toxicological Pathology
16. Molecular Pathology: Applications in Nonclinical Drug Development
17. Biomarkers in Nonclinical Drug Development
IV. Biostatistics, Regulatory Toxicology, and Role of Study Directors
18. Biostatistics for Toxicologists
19. Regulatory Toxicology
20. Role of Study Director and Study Monitor in Drug Development Safety Studies

Section V. Specialty Route of Administration
21. Infusion Toxicology and Techniques
22. Photosafety Assessment

Section VI. Nonclinical Development of Monoclonal Antibodies, Stem Cells, Oncogenic and Non-Oncogenic Drugs, Oligonucleotides, and Vaccines
23. Preclinical Development of Monoclonal Antibodies
24. Nonclinical Safety Assessment of Cell-Based Therapies
25. Nonclinical Development of Antiviral Drugs
26. Nonclinical Assessment of Anti-diabetic drugs
27. Safety Assessments of Cancer Immunotherapy Drugs
28. Application of Micro-physiological systems to enhance drug safety assessment
29. Use of Humanized mice in Safety Assessment
30. Safety Assessment of Cell and Gene Therapy
31. Preclinical Development of Oncology Drugs
32. Preclinical Toxicology of Vaccines
33. Overview of the Nonclinical Development Strategies and Class-Effects of Oligonucleotide-Based Therapeutics

Section VII. Safety Evaluation of Ocular Drugs, Botanical Products, and Medicinal Devices
34. Safety Evaluation of Ocular Drugs
35. Safety Assessment of Targeted Protein Degraders (TBD)
36. Biocompatibility Evaluation of Medical Devices

Section VIII. Predictive Toxicology, Toxicometabolomics, Toxicogenomics, and Imaging
37. Application of Evolving Computational and Biological Platforms for Chemical Safety Assessment
38. Use of Imaging for Preclinical Evaluation
39. Drug Development Challenges and Opportunities Post-Pandemic