A Comprehensive Guide to Toxicology in Nonclinical Drug Development

A Comprehensive Guide to Toxicology in Nonclinical Drug Development, Second Edition, is a valuable reference 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.

Thoroughly updated to reflect the latest scientific advances and with increased coverage of international regulatory guidelines, this second edition is an essential and practical resource for all toxicologists involved in nonclinical testing in industry, academic, and regulatory settings.

Provides unique content that is not always covered together in one comprehensive resource, including chapters on stem cells, abuse liability, biomarkers, inhalation toxicology, biostatistics, and moreUpdated with the latest international guidelines for nonclinical toxicology in both small and large moleculesIncorporates practical examples in order to illustrate day-to-day activities and the expectations associated with working in nonclinical toxicology

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

Section II. Toxicological Studies and Ind Application, and First In-Human Clinical Trial 5. Acute, Subacute, Subchronic, and Chronic General Toxicity Testing for Preclinical Drug Development 6. Genetic Toxicology Testing 7. Contemporary Practices in Core Safety Pharmacology Assessments 8. Preparation of a Preclinical Dossier to Support an Investigational New Drug (IND) Application and First-In-Human Clinical Trial 9. Developmental and Reproductive Toxicology 10. Immunotoxicology Assessment in Drug Development 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. Preclinical Development of Nononcogenic Drugs (Small and Large Molecules) 26. Preclinical Development of Oncology Drugs 27. Preclinical Toxicology of Vaccines 28. 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 29. Safety Evaluation of Ocular Drugs 30. Nonclinical Safety Assessment of Botanical Products 31. Biocompatibility Evaluation of Medical Devices

Section VIII. Predictive Toxicology, Toxicometabolomics, Toxicogenomics, and Imaging 32. Application of Evolving Computational and Biological Platforms for Chemical Safety Assessment 33. Toxicometabolomics: Technology and Applications 34. Toxicogenomics in Preclinical Development 35. Use of Imaging for Preclinical Evaluation