Statistical Monitoring in Clinical Trials: Best Practices for Detecting Data Anomalies Suggestive of Fabrication or Misconduct (English)
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- New search for: Knepper, David
- New search for: Lindblad, Anne S.
- New search for: Sharma, Gaurav
- New search for: Gensler, Gary R.
- New search for: Manukyan, Zorayr
- New search for: Matthews, Abigail G.
- New search for: Seifu, Yodit
- New search for: Knepper, David
- New search for: Lindblad, Anne S.
- New search for: Sharma, Gaurav
- New search for: Gensler, Gary R.
- New search for: Manukyan, Zorayr
- New search for: Matthews, Abigail G.
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In:
Therapeutic Innovation & Regulatory Science
;
50
, 2
; 144-154
;
2016
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ISSN:
- Article (Journal) / Electronic Resource
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Title:Statistical Monitoring in Clinical Trials: Best Practices for Detecting Data Anomalies Suggestive of Fabrication or Misconduct
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Contributors:Knepper, David ( author ) / Lindblad, Anne S. ( author ) / Sharma, Gaurav ( author ) / Gensler, Gary R. ( author ) / Manukyan, Zorayr ( author ) / Matthews, Abigail G. ( author ) / Seifu, Yodit ( author )
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Published in:Therapeutic Innovation & Regulatory Science ; 50, 2 ; 144-154
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Publisher:
- New search for: Springer International Publishing
- New search for: Springer Nature
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Place of publication:[New York]
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Publication date:2016
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ISSN:
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ZDBID:
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DOI:
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Type of media:Article (Journal)
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Type of material:Electronic Resource
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Language:English
- New search for: 44.38 / 44.38
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Source:
Table of contents – Volume 50, Issue 2
The tables of contents are generated automatically and are based on the data records of the individual contributions available in the index of the TIB portal. The display of the Tables of Contents may therefore be incomplete.
- 143
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Quite a Third BirthdaySpielberg, Stephen P. et al. | 2016
- 144
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Statistical Monitoring in Clinical Trials: Best Practices for Detecting Data Anomalies Suggestive of Fabrication or MisconductKnepper, David / Lindblad, Anne S. / Sharma, Gaurav / Gensler, Gary R. / Manukyan, Zorayr / Matthews, Abigail G. / Seifu, Yodit et al. | 2016
- 155
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Birth Control in Clinical Trials: Industry Survey of Current Use Practices, Governance, and MonitoringStewart, J. / Breslin, W. J. / Beyer, B. K. / Chadwick, K. / De Schaepdrijver, L. / Desai, M. / Enright, B. / Foster, W. / Hui, J. Y. / Moffat, G. J. et al. | 2016
- 169
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Who Said It Better? A Test of Wording Differences in the MedWatch “Toll-Free Statement” for Consumer Reporting of Side Effects in Direct-to-Consumer Television AdvertisementsAikin, Kathryn J. / O’Donoghue, Amie C. / Sullivan, Helen W. / Betts, Kevin R. / Squire, Claudia et al. | 2016
- 174
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Community Opinions on the Collection and Use of Historical Control Data in Nonclinical Toxicity StudiesMihalcik, Lauren Murphree / Bausman, Megan / Brown, Paul / Everds, Nancy / Feldmann, Jennifer / Henck, Judith / Potenta, Dan / Sims, John / Zandee, Joyce et al. | 2016
- 188
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Statistical Analysis of Cumulative Serious Adverse Event Data From Development Safety Update ReportsDavis, Brian / Southworth, Harry et al. | 2016
- 195
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CBER’s Experience With Adaptive Design Clinical TrialsLin, Min / Lee, Shiowjen / Zhen, Boguang / Scott, John / Horne, Amelia / Solomon, Ghideon / Russek-Cohen, Estelle et al. | 2016
- 204
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The Score Card Approach: A First Step Toward an Evidence-based Differentiation Assessment for TabletsPekari, Klaus / Fürst, Thomas / Gössl, Rüdiger / Dudhedia, Mayur S. / Segretario, James / Sommer, Florian / Watson, Patricia et al. | 2016
- 213
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Profit Evaluations When Adaptation by Design Is AppliedDe Martini, Daniele et al. | 2016
- 221
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Comparative Analysis Between the Top-Selling Drugs in the Japanese Pharmaceutical Market and Those in the United States, the United Kingdom, France, and GermanyShibata, Shoyo / Uemura, Ryotaro / Suzuki, Takeshi et al. | 2016
- 228
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Evaluation of Safety Profiles of Blood Cancer Drugs Approved in JapanKubota, Sachie / Saito, Kazuyuki / Ono, Shunsuke / Kodama, Yasuo et al. | 2016
- 236
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Pharmaceutical Pricing Policies and Procedures in Saudi Arabia: A Narrative ReviewKhan, Tahir Mehmood / Emeka, Promise / Suleiman, Amal Khalil / Alnutafy, Fahad Sahood / Aljadhey, Hisham et al. | 2016
- 241
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Validation of Prognostic Marker Tests: Statistical Lessons Learned From Regulatory ExperienceTang, Rong / Pennello, Gene et al. | 2016