Drug safety assessment in clinical trials /
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Imprint: | New York : Dekker, c1993. |
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Description: | x, 437 p. : ill. ; 24 cm. |
Language: | English |
Series: | Statistics, textbooks and monographs v. 138 |
Subject: | Drugs -- Testing Drugs -- Testing -- Statistical methods. Drugs -- Toxicology Drug Evaluation -- methods Clinical Trials -- methods Drugs -- Testing. Drugs -- Testing -- Statistical methods. Drugs -- Toxicology. |
Format: | Print Book |
URL for this record: | http://pi.lib.uchicago.edu/1001/cat/bib/1497246 |
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245 | 0 | 0 | |a Drug safety assessment in clinical trials / |c edited by Gene Sogliero-Gilbert. |
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300 | |a x, 437 p. : |b ill. ; |c 24 cm. | ||
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440 | 0 | |a Statistics, textbooks and monographs |v v. 138 | |
504 | |a Includes bibliographical references and index. | ||
505 | 0 | 0 | |g 1. |t Preclinical Drug Safety Evaluation / |r James T. Mayne -- |g 2. |t Adverse Drug Events in Clinical Trials / |r Deborah S. Kirby -- |g 3. |t Laboratory Testing in Clinical Trials / |r Deborah S. Kirby -- |g 4. |t Drug Research in the Elderly / |r Piet M. Hooymans and Robert Janknegt -- |g 5. |t Drug Assessment in Critical Illness / |r M. I. Bowden and J. F. Bion -- |g 6. |t Laboratory Data in Multicenter Trials: Monitoring, Adjustment, and Summarization / |r Lawrence K. Oliver and Christy Chuang-Stein -- |g 7. |t The Genie Score: A Multivariate Assessment of Laboratory Abnormalities / |r Gene Sogliero-Gilbert, Lonni Zubkoff-Schulz and Naitee Ting -- |g 8. |t Laboratory Parameters and Drug Safety / |r Norman E. Pitts -- |g 9. |t A Unified Approach to the Analysis of Safety Data in Clinical Trials / |r Christy Chuang-Stein and Noel R. Mohberg -- |g 10. |t The Use of Hazard Functions in Safety Analysis / |r David S. Salsburg -- |g 11. |t Meta-Analysis of Drug Safety Data / |r Gary G. Koch, Judith E. Schmid, Janet M. Begun and William C. Maier -- |g 12. |t Design and Analysis Considerations for Safety Data, Particularly Adverse Events / |r Karl E. Peace -- |g 13. |t Clinical Trial Adverse Drug Experience Reporting Requirements in the Major Countries: One Manufacturer's Approach / |r Max W. Talbott and Ellen D. Kelso -- |g 14. |t Safety Surveillance / |r Norman E. Pitts -- |g 15. |t Postmarketing Surveillance: Applications and Limitations, with Special Reference to the Fluoroquinolones / |r Robert Janknegt and Yechiel A. Hekster. |
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650 | 0 | |a Drugs |x Testing |x Statistical methods. | |
650 | 0 | |a Drugs |x Toxicology |0 http://id.loc.gov/authorities/subjects/sh85039757 | |
650 | 2 | |a Drug Evaluation |x methods | |
650 | 2 | |a Clinical Trials |x methods | |
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