Pharmaceutical statistics

Keyphrases

Publications

2024

Sarah Janssen
Introduction to qualification and validation of an immunoassay. Pharmaceutical statistics (2024)
José L Jiménez, Isobel Barrott, Francesca Gasperoni, Dominic Magirr
Visualizing hypothesis tests in survival analysis under anticipated delayed effects. Pharmaceutical statistics (2024)
Lindsay R Berry, Joe Marion, Scott M Berry, Kert Viele
Optimal sample size division in two-stage seamless designs. Pharmaceutical statistics (2024)
Minghong Yao, Yulong Jia, Fan Mei, Yuning Wang, Kang Zou, Ling Li, Xin Sun
Comparing various Bayesian random-effects models for pooling randomized controlled trials with rare events. Pharmaceutical statistics (2024)
Philip S Boonstra, Daniel R Owen, Jian Kang
Shrinkage priors for isotonic probability vectors and binary data modeling, with applications to dose-response modeling. Pharmaceutical statistics (2024)
François Haguinet, Fabian Tibaldi, Christophe Dessart, Andrew Bate
Tree-temporal scan statistics for safety signal detection in vaccine clinical trials. Pharmaceutical statistics (2024)
Jos Weusten, Jianfang Hu
Predictive Ppk calculations for biologics and vaccines using a Bayesian approach - a tutorial. Pharmaceutical statistics (2024)
Todd DeVries, Kevin J Carroll, Sandra A Lewis
A practical guide to the appropriate analysis of eGFR data over time: A simulation study. Pharmaceutical statistics (2024)
Elli Makariadou, Xuechen Wang, Nicholas Hein, Negera W Deresa, Kathy Mutambanengwe, Bie Verbist, Olivier Thas
Synergy detection: A practical guide to statistical assessment of potential drug combinations. Pharmaceutical statistics (2024)
Anders Granholm, Theis Lange, Michael O Harhay, Anders Perner, Morten Hylander Möller, Benjamin Skov Kaas-Hansen
Effects of sceptical priors on the performance of adaptive clinical trials with binary outcomes. Pharmaceutical statistics (2024)
Shiwei Cao, Sin-Ho Jung
Estimation of the odds ratio from multi-stage randomized trials. Pharmaceutical statistics (2024)
Andrea Callegaro, Yongyi Luo, Naveen Karkada, Toufik Zahaf
Dynamic borrowing of historical controls adjusting for covariates in vaccine efficacy clinical trials. Pharmaceutical statistics (2024)
Julie Kjaerulff Furberg, Per Kragh Andersen, Thomas Scheike, Henrik Ravn
Simulation-based sample size calculations of marginal proportional means models for recurrent events with competing risks. Pharmaceutical statistics (2024)
Wei-Chen Chen, Nelson Lu, Chenguang Wang, Heng Li, Changhong Song, Ram Tiwari, Yunling Xu, Lilly Q Yue
A propensity score-integrated approach for leveraging external data in a randomized controlled trial with time-to-event endpoints. Pharmaceutical statistics (2024)
Kjell Johnson, Max Kuhn
What they forgot to tell you about machine learning with an application to pharmaceutical manufacturing. Pharmaceutical statistics (2024)
Cheng-Han Yang, Guanghui Cheng, Ruitao Lin
On the relative conservativeness of Bayesian logistic regression method in oncology dose-finding studies. Pharmaceutical statistics (2024)
Connor Celum, Mark Conaway
A model-assisted design for partially or completely ordered groups. Pharmaceutical statistics (2024)
Alexander Fierenz, Antonia Zapf
Current developments of the estimand concept. Pharmaceutical statistics (2024)
Leandro Garcia Barrado, Tomasz Burzykowski
Using an early outcome as the sole source of information of interim decisions regarding treatment effect on a long-term endpoint: The non-Gaussian case. Pharmaceutical statistics (2024)
Marcel Wolbers, Alessandro Noci, Paul Delmar, Sean Yiu, Jonathan W Bartlett
Rejoinder to the letter: "Standard and reference-based conditional mean imputation: Regulators and trial statisticians be aware!" Pharmaceutical statistics (2024)
Suzie Cro, Tim P Morris, James H Roger, James R Carpenter
Comments on 'standard and reference-based conditional mean imputation': Regulators and trial statisticians be aware! Pharmaceutical statistics (2024)
Alan R Vazquez, Weng Kee Wong
Mathematical programming tools for randomization purposes in small two-arm clinical trials: A case study with real data. Pharmaceutical statistics (2024)
Vinicius Bonato, Szu-Yu Tang, Matilda Hsieh, Yao Zhang, Shibing Deng
Experimental design considerations and statistical analyses in preclinical tumor growth inhibition studies. Pharmaceutical statistics (2024)
Sevinc Puren Yucel Karakaya, İlker Ünal
Balance diagnostics in propensity score analysis following multiple imputation: A new method. Pharmaceutical statistics (2024)
Zhiwei Zhang, Carrie Nielson, Ching-Yi Chuo, Zhishen Ye
Information-based group sequential design for post-market safety monitoring of medical products using real world data. Pharmaceutical statistics (2024)
Jonathan M Siegel, Hans Jochen Weber, Stefan Englert, Feng Liu, Michelle Casey, null null
Time-to-event estimands and loss to follow-up in oncology in light of the estimands guidance. Pharmaceutical statistics (2024)
Anders Granholm, Theis Lange, Michael O Harhay, Anders Perner, Morten Hylander Möller, Benjamin Skov Kaas-Hansen
Effects of sceptical priors on the performance of adaptive clinical trials with binary outcomes. Pharmaceutical statistics (2024)
Marietta Kirchner, Stefanie Schüpke, Meinhard Kieser
Optimal sample size allocation for two-arm superiority and non-inferiority trials with binary endpoints. Pharmaceutical statistics (2024)
Fasheng Li, Beverly Nickerson, Les Van Alstine, Ke Wang
Statistical approaches to evaluate in vitro dissolution data against proposed dissolution specifications. Pharmaceutical statistics (2024)
Carl-Fredrik Burman, Erik Hermansson, David Bock, Stefan Franzén, David Svensson
Digital twins and Bayesian dynamic borrowing: Two recent approaches for incorporating historical control data. Pharmaceutical statistics (2024)
David Potter, Thomas Bradstreet, Davit Sargsyan, Xiao Tan, Vinicius Bonato, Dingzhou Li, John Liang, Ondrej Libiger, Jocelyn Sendecki, John Stansfield, Kanaka Tatikola, Jialin Xu, Brandy Campbell
The partnership between statisticians and the Institutional Animal Care and Use Committee (IACUC). Pharmaceutical statistics (2024)
Awa Diop, Alind Gupta, Sabrina Mueller, Louis Dron, Ofir Harari, Heather Berringer, Vinusha Kalatharan, Jay J H Park, Miceline Mésidor, Denis Talbot
Assessing the performance of group-based trajectory modeling method to discover different patterns of medication adherence. Pharmaceutical statistics (2024)
Qing Xia, Kentaro Takeda, Yusuke Yamaguchi, Jun Zhang
A generalized Bayesian optimal interval design for dose optimization in immunotherapy. Pharmaceutical statistics (2024)
Jialuo Liu, Dong Xi
Covariate adjustment and estimation of difference in proportions in randomized clinical trials. Pharmaceutical statistics (2024)
Björn Bornkamp, Silvia Zaoli, Michela Azzarito, Ruvie Martin, Carsten Philipp Müller, Conor Moloney, Giulia Capestro, David Ohlssen, Mark Baillie
Predicting subgroup treatment effects for a new study: Motivations, results and learnings from running a data challenge in a pharmaceutical corporation. Pharmaceutical statistics (2024)
Charles C Liu, Ron Xiaolong Yu, Murray Aitkin
The flaw of averages: Bayes factors as posterior means of the likelihood ratio. Pharmaceutical statistics (2024)

volume 23, number 3, 2024

Jinglin Zhong, David Petullo
Application of hypothetical strategies in acute pain. Pharmaceutical statistics 23 (3) (2024)
Oleksandr Sverdlov, Vance W Berger, Kerstine Carter
On "Re-randomization tests as sensitivity analyses to confirm immunological noninferiority of an investigational vaccine: Case study" by Luca Grassano et al. (2023, Pharmaceutical Statistics). Pharmaceutical statistics 23 (3) (2024)
Stig Johan Wiklund, Katharine Thorn, Heiko Götte, Kimberley Hacquoil, Gaelle Saint-Hilary, Alex Carlton, null null
Going beyond probability of success: Opportunities for statisticians to influence quantitative decision-making at the portfolio level. Pharmaceutical statistics 23 (3) (2024)
Masahiro Kojima, Shunichiro Orihara
Frailty model with change points for survival analysis. Pharmaceutical statistics 23 (3) (2024)

volume 23, number 4, 2024

Philip S Boonstra, Daniel R Owen, Jian Kang
Shrinkage priors for isotonic probability vectors and binary data modeling, with applications to dose-response modeling. Pharmaceutical statistics 23 (4) (2024)
Zhiqiang Cao, Youngjoo Cho, Fan Li
Transporting randomized trial results to estimate counterfactual survival functions in target populations. Pharmaceutical statistics 23 (4) (2024)
Qing Xia, Kentaro Takeda, Yusuke Yamaguchi, Jun Zhang
A generalized Bayesian optimal interval design for dose optimization in immunotherapy. Pharmaceutical statistics 23 (4) (2024)
Björn Bornkamp, Silvia Zaoli, Michela Azzarito, Ruvie Martin, Carsten Philipp Müller, Conor Moloney, Giulia Capestro, David Ohlssen, Mark Baillie
Predicting subgroup treatment effects for a new study: Motivations, results and learnings from running a data challenge in a pharmaceutical corporation. Pharmaceutical statistics 23 (4) (2024)
Cheng-Han Yang, Guanghui Cheng, Ruitao Lin
On the relative conservativeness of Bayesian logistic regression method in oncology dose-finding studies. Pharmaceutical statistics 23 (4) (2024)
Ahrim Youn, Jiarui Chi, Yue Cui, Hui Quan
A case study: Assessing the efficacy of the revised dosage regimen via prediction model for recurrent event rate using biomarker data. Pharmaceutical statistics 23 (4) (2024)
Sin-Ho Jung
Sample size calculation for comparing two ROC curves. Pharmaceutical statistics 23 (4) (2024)
Paul Meyvisch, Mitra Ebrahimpoor
On sample size calculation in drug interaction trials. Pharmaceutical statistics 23 (4) (2024)
Awa Diop, Alind Gupta, Sabrina Mueller, Louis Dron, Ofir Harari, Heather Berringer, Vinusha Kalatharan, Jay J H Park, Miceline Mésidor, Denis Talbot
Assessing the performance of group-based trajectory modeling method to discover different patterns of medication adherence. Pharmaceutical statistics 23 (4) (2024)
Charles C Liu, Ron Xiaolong Yu, Murray Aitkin
The flaw of averages: Bayes factors as posterior means of the likelihood ratio. Pharmaceutical statistics 23 (4) (2024)