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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…mehr
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.
Provides updated, unique content not covered in one comprehensive resource, including chapters on stem cells, antiviral drugs, anti-diabetic drugs, and immunotherapy
Includes the latest international guidelines for nonclinical toxicology in both small and large molecules
Incorporates practical examples in order to illustrate day-to-day activities and expectations associated with working in nonclinical toxicology
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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
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
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