A comprehensive guide to toxicology in nonclinical drug development

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 toxicolo...

وصف كامل

محفوظ في:
التفاصيل البيبلوغرافية
المؤلف الرئيسي: Faqi, Ali S.
التنسيق: Livre numérique
اللغة:Anglais
منشور في: London : Academic Press 2024.
Paris : Cyberlibris
الموضوعات:
الوصول للمادة أونلاين:Accès Université d'Orléans et IFPM
ملاحظة: Couverture. https://static2.cyberlibris.com/books_upload/300pix/9780323984621.jpg
Cyberlibris (ScholarVox) corpus Santé
Autres localisations: Voir dans le Sudoc
Edition sous un autre format:• A comprehensive guide to toxicology in nonclinical drug development, edited by Ali S. Faqi,..., 3rd edition, 2024, London, Academic Press, 1 vol. (XVII-1053 p.), 978-0-323-85704-8
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245 1 0 |a A comprehensive guide to toxicology in nonclinical drug development   |c edited by Ali S. Faqi,... 
260 |a London :  |b Academic Press. 
260 |a Paris :  |b Cyberlibris,  |c 2024. 
500 |a Couverture. https://static2.cyberlibris.com/books_upload/300pix/9780323984621.jpg 
500 |a Cyberlibris (ScholarVox) corpus Santé 
504 |a Bibliogr. en fin de chapitres. Index 
505 0 |a Section I. Drug Discovery, Metabolism, and Toxicokinetic -- Section II. Toxicological Studies and IND Application and First-In-Human Clinical Trial and Abuse Liability -- Section III. Clinical Pathology, Toxicological Pathology, Molecular Biology, and Biomarkers -- Section IV. Biostatistics, Regulatory Toxicology, and Role of Study Directors -- Section V. Specialty Route of Administration -- Section VI. Nonclinical Development of Monoclonal Antibodies, Stem Cells, Oncogenic and Non-Oncogenic Drugs, Oligonucleotides, and Vaccines -- Section VII. Nonclinical Development of Oncogenic and Nononcogenic Drugs and Oligonucleotidebased Therapies and Vaccines -- Section VIII. Safety Evaluation of Ocular Drugs, Botanical Products, and Medicinal Devices -- Section IX. Predictive Toxicology and Imaging -- 1. Introduction to Drug Development -- 2. Critical Aspects of Integrated Nonclinical Drug Development: Concepts, Strategies, and Potential Pitfalls -- 3. Overview of ADME Science -- 4. Pharmacokinetics and Toxicokinetics in Drug Development -- 5. Development of Preclinical Formulations for Toxicology Studies -- 6. Acute, Subacute, Subchronic, and Chronic General Toxicity Testing for Preclinical Drug Development -- 7. Genetic Toxicology Testing -- 8. The Preparation of a Preclinical Dossier to Support an Investigational New Drug 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 -- 14. Clinical Pathology in Nonclinical Toxicity Studies -- 15. Best Practice in Toxicologic Pathology -- 16. Molecular Pathology: Applications in Nonclinical Drug Development -- 17. Biomarkers in Nonclinical Drug Development -- 18. Biostatistics for Toxicologists -- 19. Regulatory Toxicologyc20. Study Directors and Study Monitors in Drug Development Safety Studies -- 21. Infusion Toxicology and Techniques -- 22. Photosafety AssessmentbIntroduction -- 23. Preclinical Development of Monoclonal Antibodies -- 24. Preclinical Development of Antibody-Drug Conjugates -- 25. Nonclinical Safety Assessment of Cell and Gene Therapies -- 26. How Gene Editing Is Changing Drug Development -- 27. Nonclinical Development of Oncology Drugs -- 28. Preclinical Development of Nononcogenic Drugs (Small and Large Molecules) -- 29. Overview of the Nonclinical Development Strategies and Class Effects of Oligonucleotide-based Therapeutics -- 30. Animal Models for Infectious Disease Vaccine Development -- 31. Preclinical Toxicology of Vaccines -- 32. Safety Evaluation of Ocular Drugs -- 33. Nonclinical Safety Assessment of Botanical Products -- 34. Biocompatibility Evaluation of Medical Devices -- 35. Application of Evolving New Approach Methodologies for Chemical Safety Assessment -- 36. Use of Imaging for Preclinical Evaluation 
506 |a L'accès en ligne est réservé aux établissements ou bibliothèques ayant souscrit l'abonnement. Cyberlibris 
520 |a 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 
650 |a Médicaments  |x Tests de toxicité 
650 |a Médicaments  |x Toxicologie 
650 |a Chimie pharmaceutique 
650 |a Médicaments  |x Mise au point 
650 |a Chimie toxicologique 
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