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A Comprehensive Guide to Toxicology in Nonclinical Drug Development de Ali S. Faqi

A Comprehensive Guide to Toxicology in Nonclinical Drug Development

Editat de Ali S. Faqi
en Limba Engleză Hardback – 22 noi 2016
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 more
  • Updated with 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 the expectations associated with working in nonclinical toxicology
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Specificații

ISBN-13: 9780128036204
ISBN-10: 0128036206
Pagini: 986
Ilustrații: Approx. 300 illustrations
Dimensiuni: 216 x 276 x 55 mm
Greutate: 2.79 kg
Ediția:2. Auflage.
Editura: ELSEVIER SCIENCE

Public țintă

Toxicologists working in nonclinical drug development, toxicology professors and students, regulatory toxicologists, medical and veterinary scientists

Cuprins

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