04137cam a2200469 i 450000100090000000300040000900500170001300800410003001000170007101600200008802000250010802000220013302200180015503500240017304000520019704200080024905000220025713000710027924501010035025000200045126400670047126400110053830000700054933600260061933700280064533800270067350001210070050400510082150520120087252003840288465000230326865000220329165000250331365000300333865000200336865000750338865000290346365000510349265000480354365000490359170000270364019042201GZU20221018142748.0160404t20172017ne ac    b    001 0 eng c  a  20169378367 a1017172032DNLM  a9780128036204 (hbk.)  a0128036206 (hbk.)  a9780128036204  a(OCoLC)ocn972508192  aNLMbengcNLMerdadOCLCFdLIPdAU@dOCLCOdDLC  apcc00aRA1238b.COM 20170 aComprehensive guide to toxicology in preclinical drug development.12aA comprehensive guide to toxicology in nonclinical drug development /cedited by Ali Said Faqi,   aSecond edition. 1aAmsterdam :bAcademic Press is an imprint of Elsevier,c[2017] 4c©2017  axiii, 971 pages :billustrations (some color), portraits ;c29 cm  atextbtxt2rdacontent  aunmediatedbn2rdamedia  avolumebnc2rdacarrier  aPreceded by Comprehensive guide to toxicology in preclinical drug development / edited by Ali S. Faqi. 1st ed. 2013.  aIncludes bibliographical references and index.  a1. Introduction; 2. ADME in Drug Discovery; 3. Pharmacokinetics and Toxicokinetics; 4. Acute, Sub-Acute, Sub-Chronic and Chronic, Dermal and Inhalation Toxicology; 5. Contemporary Practices in Core Safety Pharmacology Assessments; 6. Genetic Toxicology Testing; 7. Clinical Pathology; 8. Best Practice in Toxicologic Pathology; 9. Molecular Pathology: Applications in Nonclinical Drug Development; 10. Infusion Toxicology and Techniques; 11. The Preparation of a Nonclinical Dossier to Support an Investigational New Drug (IND) Application and First-in-Human Clinical Trials; 12. Developmental and Reproductive Toxicology; 13. Immunotoxicology Assessment in Drug Development; 14. Juvenile Toxicity Testing to Support Clinical Trials in the Pediatric Population; 15. Photosafety: Current Methods and Future Direction; 16. Dermal Toxicology; 17. Inhalation Toxicology; 18. Nonclinical Evaluation of Carcinogenicity using the Rodent Two-Year Bioassay and Carcinogenicity Evaluations using Genetically Engineered Animals; 19 Current Strategies for Abuse Liability Assessment of New Chemical Entities; 20. Nonclinical Development of Monoclonal Antibodies; 21. Nonclinical Development of Non-Oncogenic Drugs (Small and Large Molecules); 22. Nonclinical Development of Oncology Drugs; 23. Safety Evaluation of Ocular Drugs; 24. Nonclinical toxicology of Vaccines; 25. Stem Cells In Nonclinical Toxicology; 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. Biostatistics for Toxicologists; 30. Role of Study Director and Study Monitor in Drug Development; 31. Use of Imaging for Nonclinical Evaluation; 32. Biomarkers in Toxicology; 33. Predictive Toxicology: Biological Assay Platforms; 34. Toxicometabolomics: Technology and Applications; 35. Toxicogenomics in Nonclinical Development; 36. Nonclinical Testing of Medical Devices; 37. The Pitfalls of Drug Development  aThis book is 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 0aDrugsxToxicology. 0aDrug development. 0aClinical toxicology.12aDrug Evaluationxmethods.22aDrug Discovery.22aDrug-Related Side Effects and Adverse Reactionsxprevention & control.22aToxicity Testsxmethods. 7aClinical toxicology.2fast0(OCoLC)fst00864428 7aDrug development.2fast0(OCoLC)fst00898670 7aDrugsxToxicology.2fast0(OCoLC)fst008989581 aFaqi, Ali S.,eeditor.