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| LEADER |
00000cam a2200000 7i4500 |
| 001 |
0000092125 |
| 005 |
20200311093000.0 |
| 008 |
160324s2017 njua b 001 0 eng |
| 020 |
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|a 9781119097396
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| 020 |
|
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|a 9781119097402
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| 020 |
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|a 9781119097419
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| 040 |
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|a UniSZA
|e rda
|
| 050 |
0 |
0 |
|a RA1238
|b .G33 2017
|
| 060 |
1 |
0 |
|a QV 771
|b .G123 2017
|
| 090 |
0 |
0 |
|a RA1238
|b .G33 2017
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| 100 |
1 |
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|a Gad, Shayne C. ,
|d 1948- ,
|e author
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| 245 |
1 |
0 |
|a Drug safety evaluation
|c Shayne Cox Gad
|
| 250 |
|
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|a 3rd ed
|
| 264 |
|
1 |
|a Hoboken, New Jersey :
|b Wiley
|c c2017
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| 300 |
|
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|a xxvii, 886 pages :
|b illustration ;
|c 29 cm.
|
| 336 |
|
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|a text
|2 rdacontent
|
| 337 |
|
|
|a unmediated
|2 rdamedia
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| 338 |
|
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|a volume
|2 rdacarrier
|
| 504 |
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|a Includes bibliographical references and index
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| 505 |
0 |
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|a 1. The Drug Development Process And The Global Pharmaceutical Marketplace -- 2. Regulation Of Human Pharmaceutical Safety -- 3. Data Mining -- 4. Screens In Safety And Hazard Assessment -- 5. Formulations, Routes, And Dosage Regimens -- 6. Nonclinical Manifestations, Mechanisms, And End Points Of Drug Toxicity -- 7. Pilot Toxicity Testing In Drug Safety Evaluation -- 8. Repeat-Dose Toxicity Studies -- 9. Genotoxicity -- 10. Qsar Tools For Drug Safety -- 11. Immunotoxicology In Drug Development -- 12. Nonrodent Animal Studies -- 13. Developmental And Reproductive Toxicity Testing -- 14. Carcinogenicity Studies -- 15. Histopathology In Nonclinical Pharmaceutical Safety Assessment -- 16. Irritation And Local Tissue Tolerance In Pharmaceutical Safety Assessment -- 17. Pharmacokinetics And Toxicokinetics In Drug Safety Evaluation -- 18. Safety Pharmacology -- 19. Special Concerns For The Preclinical Evaluation Of Biotechnology Products --
Safety Assessment Of Inhalant Drugs And Dermal Route Drugs -- 20. Special Case Products -- 21. Special Case Products -- 22. Pediatric Product Safety Assessment (2006 Guidance, Including Juvenile Toxicology) -- 23. Use Of Imaging, Imaging Agents, And Radiopharmaceuticals In Nonclinical Toxicology -- 24. Occupational Toxicology In The Pharmaceutical Industry -- 25. Strategy And Phasing For Nonclinical Drug Safety Evaluation In The Discovery And Development Of Pharmaceuticals -- 26. The Application Of In Vitro Techniques In Drug Safety Assessment -- 27. Evaluation Of Human Tolerance And Safety In Clinical Trials -- 28. Postmarketing Safety Evaluation -- 29. Statistics In Pharmaceutical Safety Assessment -- 30. Combination Products -- 31. Qualification Of Impurities, Degradants, Residual Solvents, Metals, And Leachables In Pharmaceuticals -- 33. Tissue, Cell, And Gene Therapy --
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| 520 |
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|a "Provides practical guidance to solve scientific and regulatory issues in preclinical safety assessment, early clinical drug development, and post-approval impurity issues"--
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| 650 |
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0 |
|a Drug Evaluation
|
| 650 |
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0 |
|a Drug Evaluation, Preclinical
|
| 650 |
|
0 |
|a Product Surveillance, Postmarketing
|
| 999 |
|
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|a 1000169175
|b Book
|c OPEN SHELF (30 DAYS)
|e Tembila Campus
|