Assessment of Consistency of Treatment Effects in Multiregional Clinical Trials
Quan, Hui, Li, Mingyu, Chen, Joshua, Gallo, Paul, Binkowitz, Bruce, Ibia, Ekapimo, Tanaka, Yoko, Ouyang, Soo Peter, Luo, Xiaolong, Li, Gang, Menjoge, Shailendra, Talerico, Steven, Ikeda, Kimitoshi
Published in Therapeutic innovation & regulatory science (01.09.2010)
Published in Therapeutic innovation & regulatory science (01.09.2010)
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Good Practices for Adaptive Clinical Trials in Pharmaceutical Product Development
Gaydos, Brenda, Anderson, Keaven M., Berry, Donald, Burnham, Nancy, Chuang-Stein, Christy, Dudinak, Jennifer, Fardipour, Parvin, Gallo, Paul, Givens, Sam, Lewis, Roger, Maca, Jeff, Pinheiro, José, Pritchett, Yili, Krams, Michael
Published in Therapeutic innovation & regulatory science (01.09.2009)
Published in Therapeutic innovation & regulatory science (01.09.2009)
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A Quantitative Approach for Making Go/No-Go Decisions in Drug Development
Chuang-Stein, Christy, Kirby, Simon, French, Jonathan, Kowalski, Ken, Marshall, Scott, Smith, Mike K., Bycott, Paul, Beltangady, Mohan
Published in Therapeutic innovation & regulatory science (01.03.2011)
Published in Therapeutic innovation & regulatory science (01.03.2011)
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Patient-Reported Outcomes: The Example of Health-Related Quality of Life—A European Guidance Document for the Improved Integration of Health-Related Quality of Life Assessment in the Drug Regulatory Process
Chassany, Olivier, Sagnier, Pierre, Marquis, Patrick, Fullerton, Steve, Aaronson, Neil
Published in Therapeutic innovation & regulatory science (2002)
Published in Therapeutic innovation & regulatory science (2002)
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Effective Strategies for Maintaining Research Participation in Clinical Trials
Zweben, Allen, Fucito, Lisa M., O'Malley, Stephanie S.
Published in Therapeutic innovation & regulatory science (01.07.2009)
Published in Therapeutic innovation & regulatory science (01.07.2009)
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Multiple Co-primary Endpoints: Medical and Statistical Solutions: A Report from the Multiple Endpoints Expert Team of the Pharmaceutical Research and Manufacturers of America
Offen, Walter, Chuang-Stein, Christy, Dmitrienko, Alex, Littman, Gary, Maca, Jeff, Meyerson, Laura, Muirhead, Robb, Stryszak, Paul, Baddy, Alex, Chen, Kun, Copley-Merriman, Kati, Dere, Willard, Givens, Sam, Hall, David, Henry, David, Jackson, Joseph D., Krishen, Alok, Liu, Thomas, Ryder, Steve, Sankoh, A. J., Wang, Julia, Yeh, Chyon-Hwa
Published in Therapeutic innovation & regulatory science (01.01.2007)
Published in Therapeutic innovation & regulatory science (01.01.2007)
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Evaluation of Data Entry Errors and Data Changes to an Electronic Data Capture Clinical Trial Database
Mitchel, Jules T., Kim, Yong Joong, Choi, Joonhyuk, Park, Glen, Cappi, Silvana, Horn, David, Kist, Morgan, D'agostino, Ralph B.
Published in Therapeutic innovation & regulatory science (01.07.2011)
Published in Therapeutic innovation & regulatory science (01.07.2011)
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Covariate-Adjusted Difference in Proportions from Clinical Trials Using Logistic Regression and Weighted Risk Differences
Ge, Miaomiao, Durham, L. Kathryn, Meyer, R. Daniel, Xie, Wangang, Thomas, Neal
Published in Therapeutic innovation & regulatory science (01.07.2011)
Published in Therapeutic innovation & regulatory science (01.07.2011)
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Evaluation of the Characteristics of Safety Withdrawal of Prescription Drugs from Worldwide Pharmaceutical Markets-1960 to 1999
Fung, Man, Thornton, Anna, Mybeck, Kathy, Wu, Jasmanda Hsiao-hui, Hornbuckle, Ken, Muniz, Edmundo
Published in Therapeutic innovation & regulatory science (2001)
Published in Therapeutic innovation & regulatory science (2001)
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Aspects of Modernizing Drug Development Using Clinical Scenario Planning and Evaluation
Benda, Norbert, Branson, Michael, Maurer, Willi, Friede, Tim
Published in Therapeutic innovation & regulatory science (01.05.2010)
Published in Therapeutic innovation & regulatory science (01.05.2010)
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Evaluation of Blinded Independent Central Review of Tumor Progression in Oncology Clinical Trials: A Meta-analysis
Zhang, Jenny J., Chen, Huanyu, He, Kun, Tang, Shenghui, Justice, Robert, Keegan, Patricia, Pazdur, Richard, Sridhara, Rajeshwari
Published in Therapeutic Innovation & Regulatory Science (01.03.2013)
Published in Therapeutic Innovation & Regulatory Science (01.03.2013)
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Variability in Protocol Design Complexity by Phase and Therapeutic Area
Getz, Kenneth A., Campo, Rafael A., Kaitin, Kenneth I.
Published in Therapeutic innovation & regulatory science (01.07.2011)
Published in Therapeutic innovation & regulatory science (01.07.2011)
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