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|a 10.1002/9780470464151
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|n http://www3.interscience.wiley.com
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|2 22
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|a Gad, Shayne C.,
|d 1948-
|0 http://id.loc.gov/authorities/names/n85318071
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| 245 |
1 |
0 |
|a Drug safety evaluation /
|c Shayne Cox Gad.
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| 250 |
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|a 2nd ed.
|
| 264 |
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1 |
|a Hoboken, N.J. :
|b Wiley,
|c [2009]
|
| 264 |
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4 |
|c ©2009
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| 300 |
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|a 1 online resource (xi, 1182 pages) :
|b illustrations
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| 336 |
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|a text
|b txt
|2 rdacontent
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|a computer
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|a online resource
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| 500 |
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|a Electronic resource.
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| 504 |
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|a Includes bibliographical references and index.
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| 505 |
0 |
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|a Front Matter -- Drug Development Process and Global Pharmaceutical Marketplace -- Regulation of Human Pharmaceutical Safety -- Prior Art and Its Use in Safety Assessment Process -- Screens in Safety and Hazard Assessment -- Formulations, Routes, and Dosage Design -- Single-Dose (Acute) and Pilot (DRF) Toxicity Testing in Drug Safety Evaluation -- Genotoxicity -- Repeat-Dose Toxicity Studies -- Immunotoxicology in Drug Development -- Nonrodent Animal Studies -- Developmental and Reproductive Toxicity Testing -- Carcinogenicity Studies -- Histopathology in Nonclinical Pharmaceutical Safety Assessment -- Irritation and Local Tissue Tolerance in Pharmaceutical Safety Assessment -- Pharmacokinetics and Toxicokinetics in Drug Safety Evaluation -- Safety Pharmacology -- Special Concerns for Preclinical Evaluation of Biotechnology Products -- Safety Assessment of Inhalant and Dermal Route Drugs -- Special-Case Products: Imaging Agents and Oncology Drugs -- Occupational Toxicology in Pharmaceutical Industry -- Strategy and Phasing for Nonclinical Drug Safety Evaluation in Discovery and Development of Pharmaceuticals -- Application of In Vitro Techniques in Drug Safety Assessment -- Evaluation of Human Tolerance and Safety in Clinical Trials: FIM Trials and Beyond -- Postmarketing Safety Evaluation: Monitoring, Assessing, and Reporting of Adverse Drug Responses -- Statistics in Pharmaceutical Safety Assessment -- Combination Products: Drugs and Devices -- Qualification of Impurities, Degradants, Residual Solvents, and Leachables in Pharmaceuticals -- Appendix A: Selected Regulatory and Toxicological Acronyms -- Appendix B: Definition of Terms and Lexicon of Clinical Observations in Nonclinical (Animal) Studies -- Appendix C: Notable Regulatory Internet Addresses -- Appendix D: Glossary of Terms Used in Clinical Evaluation of Therapeutic Agents -- Appendix E: Common Vehicles for Nonclinical Evaluation of Therapeutic Agents -- Appendix F: Global Directory of Contract Toxicology Laboratories -- Index.
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|a Description based on print version record.
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|a Arzneimittelsicherheit.
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|a Drug Evaluation, Preclinical.
|0 https://id.nlm.nih.gov/mesh/D004353
|
| 650 |
2 |
2 |
|a Drug Evaluation.
|0 https://id.nlm.nih.gov/mesh/D004341
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| 650 |
2 |
2 |
|a Product Surveillance, Postmarketing.
|0 https://id.nlm.nih.gov/mesh/D011358
|
| 650 |
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|a Drugs
|x Testing.
|0 http://id.loc.gov/authorities/subjects/sh85039755
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| 650 |
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|a Drugs
|x Toxicology.
|0 http://id.loc.gov/authorities/subjects/sh85039757
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|a Electronic books.
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|i Print version:
|a Gad, Shayne C., 1948-
|t Drug safety evaluation.
|b 2nd ed.
|d Hoboken, N.J. : Wiley, c2009
|z 9780470464151
|w (OCoLC)657112601
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