(PDF) A Comprehensive Guide to Toxicology in Preclinical Drug Development By Ali S. Faqi

This is the PDF eBook version for A Comprehensive Guide to Toxicology in Preclinical Drug Development By Ali S. Faqi

Table of Contents

1. Introduction 2. ADME in Drug Discovery 3. Pharmacokinetics and Toxicokinetics 4. Development of Preclinical Formulations for Toxicology Studies 5. Acute, Sub-Acute, Sub-Chronic and Chronic General Toxicity Testing for Preclinical Drug Development 6. Contemporary Practices in Core Safety Pharmacology Assessments 7. Genetic Toxicology Testing 8. Clinical Pathology 9. Best Practice in Toxicologic Pathology 10. Molecular Pathology: Applications in Nonclinical Drug Development 11. Infusion Toxicology and Techniques 12. The Preparation of a Preclinical Dossier to Support an Investigational New Drug (IND) Application and First-in-Human Clinical Trials 13. Developmental and Reproductive Toxicology 14. Immunotoxicology Assessment in Drug Development 15. Juvenile Toxicity Testing to Support Clinical Trials in the Pediatric Population 16. Photosafety: Current Methods and Future Direction 17. Preclinical Evaluation of Carcinogenicity using the Rodent Two-Year Bioassay 18. Carcinogenicity Evaluations using Genetically Engineered Animals 19. Current Strategies for Abuse Liability Assessment of New Chemical Entities 20. Impact of Product Attributes on Preclinical Safety Evaluation 21. Preclinical Development of Monoclonal Antibodies 22. Preclinical Development of Non-Oncogenic Drugs (Small and Large Molecules) 23. Preclinical Development of Oncology Drugs 24. Safety Evaluation of Ocular Drugs 25. Preclinical toxicology of Vaccines 26. Overview of the Nonclinical Development Strategies and Class-Effects of Oligonucleotide-Based Therapeutics 27. Nonclinical Safety Assessment of Botanical Drugs 28. Regulatory Toxicology 29. New Drug Regulation and Approval in China 30. Biostatistics for Toxicologists 31. Role of Study Director and Study Monitor in Drug Development 32. Use of Imaging for Preclinical Evaluation 33. Predictive Toxicology: Biological Assay Platforms 34. Toxicometabolomics: Technology and Applications 35. Toxicogenomics in Preclinical Development 36. Practical Aspects of Developing In-Licensed Pharmaceutical Products: The Virtual Development Paradigm