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Pharmaceutical Statistics

IF1.4
Papers40
Citations
Journal Papers 40
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Evaluating Safety Rules in Ongoing Dose-Escalation Trials Using BOIN: A Comparative Analysis of Criteria and Their Impact on Dose-Level Safety Assessments
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PREAI
deleteEnglert, Stefan; Prior, Thomas J.; Mitra, Anirban; Sanusi, Busola; Zhang, Liangcai; Di Scala, Lilla
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Within-Trial Prognostic Score Adjustment Is Targeted Maximum Likelihood Estimation
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deleteHojbjerre-Frandsen, Emilie; Schuler, Alejandro
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An Association Test for Ordinal Outcomes in Clustered Data With Informative Cluster Size
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deleteSenevirathne, Hasika K. Wickrama; Dutta, Sandipan
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Paired and AB/BA Cross-Over Design in Early Phase Clinical Trials: A Closer Look at Within-Subject Variance Bias
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deleteWolfsegger, Martin J.; Xu, Peixin; Cotterill, Amy; Schutz, Helmut; Jaki, Thomas F.
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New, Shorter Small-Sample Intervals for Vaccine Efficacy
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deleteGasparini, Mauro; Di Trani, Vincenzo; Ratta, Marco
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Handling Missing Data in Participants with Baseline but No Post-Baseline Data
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deleteMallinckrodt, Craig; Lipkovich, Ilya; Dickson, Samuel; Hendrix, Suzanne; Molenberghs, Geert
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A Statistical Concept for Conditional Marketing Authorisation Based on the Intermediate and Final Outcomes of a Single Confirmatory Randomised Clinical Trial
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deleteLiu, Xiaofei; Thomas, Nele Henrike; Asikanius, Elina; Pothet, Caroline; Grosshennig, Anika; Koch, Armin
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Application of Causal Inference to Establish Assay Effect in the Absence of a Bridging Study: A Case Study of MenACWY-CRM Conjugate Vaccine Data
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PREAI
deleteAdani, Meike; Noirjean, Silvia; Callegaro, Andrea; Keshavan, Pavitra; Costantini, Marco
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Multiplicity Adjustment Methods for a Three-Way Crossover Bioequivalence Study
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deleteHinds, David; Grosser, Stella; Sun, Wanjie
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Leveraging Two-Stage δ Global Sensibility Analysis Method to Inform Parameter Estimation in PBPK Models
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PREAI
deleteCuquerella-Gilabert, Marina; De Carlo, Alessandro; Sanchez Herrero, Sergio; Reig-Lopez, Javier; Merino-Sanjuan, Matilde; Tosca, Elena M.; Mangas-Sanjuan, Victor; Magni, Paolo
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Unblinded by the Night: Predictive Power for Complex Bayesian Adaptive Trials When Sight Privileges Vary
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deleteGajewski, Byron J.; Beall, Jonathan; Nimkar, Kaustubh; Martin, Renee' H.
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Robust Modestly Weighted Log-Rank Tests
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deleteMagirr, Dominic; Ohrn, Fredrik
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Confidence Intervals for Validation of Analytical Procedures Under ICH Q2(R2)
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deleteFaya, Paul; Wolfe, Chad N.; Rauk, Adam P.
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