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010 _a 2016937836
016 7 _a101717203
_2DNLM
020 _a9780128036204 (hbk.)
020 _a0128036206 (hbk.)
022 _a9780128036204
035 _a(OCoLC)ocn972508192
040 _aNLM
_beng
_cNLM
_erda
_dOCLCF
_dLIP
_dAU@
_dOCLCO
_dDLC
042 _apcc
050 0 0 _aRA1238
_b.COM 2017
130 0 _aComprehensive guide to toxicology in preclinical drug development.
245 1 2 _aA comprehensive guide to toxicology in nonclinical drug development /
_cedited by Ali Said Faqi,
250 _aSecond edition.
264 1 _aAmsterdam :
_bAcademic Press is an imprint of Elsevier,
_c[2017]
264 4 _c©2017
300 _axiii, 971 pages :
_billustrations (some color), portraits ;
_c29 cm
336 _atext
_btxt
_2rdacontent
337 _aunmediated
_bn
_2rdamedia
338 _avolume
_bnc
_2rdacarrier
500 _aPreceded by Comprehensive guide to toxicology in preclinical drug development / edited by Ali S. Faqi. 1st ed. 2013.
504 _aIncludes bibliographical references and index.
505 _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
520 _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
650 0 _aDrugs
_xToxicology.
650 0 _aDrug development.
650 0 _aClinical toxicology.
650 1 2 _aDrug Evaluation
_xmethods.
650 2 2 _aDrug Discovery.
650 2 2 _aDrug-Related Side Effects and Adverse Reactions
_xprevention & control.
650 2 2 _aToxicity Tests
_xmethods.
650 7 _aClinical toxicology.
_2fast
_0(OCoLC)fst00864428
650 7 _aDrug development.
_2fast
_0(OCoLC)fst00898670
650 7 _aDrugs
_xToxicology.
_2fast
_0(OCoLC)fst00898958
700 1 _aFaqi, Ali S.,
_eeditor.
906 _a7
_bcbc
_cpccadap
_d2
_encip
_f20
_gy-gencatlg
942 _2lcc
_cBK
_eSecond edition
_h1238
_iCOM
_kRA