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Pharmaceutical Statistics
Journal Prestige (SJR): 1.494
Citation Impact (citeScore): 1
Number of Followers: 15  
 
  Hybrid Journal Hybrid journal (It can contain Open Access articles)
ISSN (Print) 1539-1604 - ISSN (Online) 1539-1612
Published by John Wiley and Sons Homepage  [1763 journals]
  • Issue Information

    • Free pre-print version: Loading...

      Abstract: Pharmaceutical Statistics, Volume 21, Issue 5, Page 815-817, September/October 2022.
      PubDate: 2022-09-16T02:11:04-07:00
      DOI: 10.1002/pst.2137
      Issue No: Vol. 21, No. 5 (2022)
       
  • An adaptive biomarker basket design in phase II oncology trials

    • Free pre-print version: Loading...

      Authors: Shufang Liu; Kentaro Takeda, Alan Rong
      Abstract: Pharmaceutical Statistics, EarlyView.
      PubDate: 2022-09-26T08:15:55-07:00
      DOI: 10.1002/pst.2264
       
  • A Bayesian phase I/II design to determine subgroup‐specific optimal dose
           for immunotherapy sequentially combined with radiotherapy

    • Free pre-print version: Loading...

      Authors: Beibei Guo; Yong Zang, Li‐Hsiang Lin, Rui Zhang
      Abstract: Pharmaceutical Statistics, EarlyView.
      PubDate: 2022-09-26T04:45:07-07:00
      DOI: 10.1002/pst.2265
       
  • A comparison of statistical methods for animal oncology studies

    • Free pre-print version: Loading...

      Authors: Tianhui Zhang; Steven J. Novick
      Abstract: Pharmaceutical Statistics, EarlyView.
      PubDate: 2022-08-31T12:35:20-07:00
      DOI: 10.1002/pst.2263
       
  • Should the two‐trial paradigm still be the gold standard in drug
           assessment'

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      Authors: Stella Jinran Zhan; Cornelia Ursula Kunz, Nigel Stallard
      Abstract: Pharmaceutical Statistics, EarlyView.
      PubDate: 2022-08-26T10:39:45-07:00
      DOI: 10.1002/pst.2262
       
  • Sensitivity analyses for the principal ignorability assumption using
           multiple imputation

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      Authors: Craig Wang; Yufen Zhang, Fabrizia Mealli, Björn Bornkamp
      Abstract: Pharmaceutical Statistics, EarlyView.
      PubDate: 2022-08-23T10:14:52-07:00
      DOI: 10.1002/pst.2260
       
  • A model selection criterion for clustered survival analysis with
           informative cluster size

    • Free pre-print version: Loading...

      Authors: Li‐Chu Chien; Li‐Ying Chang, Chung‐Wei Shen
      Abstract: Pharmaceutical Statistics, EarlyView.
      PubDate: 2022-08-23T04:31:40-07:00
      DOI: 10.1002/pst.2261
       
  • Setting the control limit at release for stability assurance

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      Authors: X. Gregory Chen; A. W. Vaart
      Abstract: Pharmaceutical Statistics, EarlyView.
      PubDate: 2022-08-17T10:50:25-07:00
      DOI: 10.1002/pst.2259
       
  • Key considerations for choosing a statistical method to deal with
           incomplete treatment adherence in pragmatic trials

    • Free pre-print version: Loading...

      Authors: Md. Belal Hossain; Mohammad Ehsanul Karim
      Abstract: Pharmaceutical Statistics, EarlyView.
      PubDate: 2022-08-03T03:19:22-07:00
      DOI: 10.1002/pst.2258
       
  • Response to the letter to the editor regarding our article ‘statistical
           methodology for highly variable compounds: A novel design approach for the
           ofatumumab phase 2 bioequivalence study’
           https://doi.org/10.1002/pst.2233

    • Free pre-print version: Loading...

      Authors: Byron Jones; Bingbing Li, Morten Bagger, Alex Goodyear, Inga Ludwig
      Abstract: Pharmaceutical Statistics, EarlyView.
      PubDate: 2022-07-20T05:27:43-07:00
      DOI: 10.1002/pst.2254
       
  • Comments on “Statistical methodology for highly variable compounds: A
           novel design approach for the Ofatumumab phase 2 bioequivalence study”

    • Free pre-print version: Loading...

      Authors: Wanjie Sun; Donald J. Schuirmann, Stella Grosser
      Abstract: Pharmaceutical Statistics, EarlyView.
      PubDate: 2022-07-20T05:17:53-07:00
      DOI: 10.1002/pst.2255
       
  • Evaluating response‐adaptive randomization procedures for recurrent
           events and terminal event data using a composite endpoint

    • Free pre-print version: Loading...

      Authors: Yu‐Lin Mau; Pei‐Fang Su
      Abstract: Pharmaceutical Statistics, EarlyView.
      PubDate: 2022-07-19T06:39:29-07:00
      DOI: 10.1002/pst.2253
       
  • A Bayesian piecewise exponential phase II design for monitoring a
           time‐to‐event endpoint

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      Authors: Yun Qing; Peter F. Thall, Ying Yuan
      Abstract: Pharmaceutical Statistics, EarlyView.
      PubDate: 2022-07-18T10:33:46-07:00
      DOI: 10.1002/pst.2256
       
  • Left truncation in linked data: A practical guide to understanding left
           truncation and applying it using SAS and R

    • Free pre-print version: Loading...

      Authors: Yanling Jin; Thanh G. N. Ton, Devin Incerti, Sylvia Hu
      Abstract: Pharmaceutical Statistics, EarlyView.
      PubDate: 2022-07-17T06:40:17-07:00
      DOI: 10.1002/pst.2257
       
  • CUSUMIN: A cumulative sum interval design for cancer phase I dose finding
           studies

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      Authors: Tomoyoshi Hatayama; Seiichi Yasui
      Abstract: Pharmaceutical Statistics, EarlyView.
      PubDate: 2022-07-14T06:20:20-07:00
      DOI: 10.1002/pst.2247
       
  • Improving early phase oncology clinical trial design: A case study

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      Authors: Alan J. Phillips; Timothy P. Clark
      Abstract: Pharmaceutical Statistics, EarlyView.
      PubDate: 2022-06-29T12:09:37-07:00
      DOI: 10.1002/pst.2252
       
  • Win ratio approach for analyzing composite time‐to‐event endpoint with
           opposite treatment effects in its components

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      Authors: Ran Liao; Sujatro Chakladar, Margaret Gamalo
      Abstract: Pharmaceutical Statistics, EarlyView.
      PubDate: 2022-06-29T02:19:24-07:00
      DOI: 10.1002/pst.2248
       
  • Estimators for handling COVID‐19‐related intercurrent events with a
           hypothetical strategy

    • Free pre-print version: Loading...

      Authors: Florian Lasch; Lorenzo Guizzaro
      Abstract: Pharmaceutical Statistics, EarlyView.
      PubDate: 2022-06-28T01:09:11-07:00
      DOI: 10.1002/pst.2244
       
  • Win statistics (win ratio, win odds, and net benefit) can complement one
           another to show the strength of the treatment effect on time‐to‐event
           outcomes

    • Free pre-print version: Loading...

      Authors: Gaohong Dong; Bo Huang, Johan Verbeeck, Ying Cui, James Song, Margaret Gamalo‐Siebers, Duolao Wang, David C. Hoaglin, Yodit Seifu, Tobias Mütze, John Kolassa
      Abstract: Pharmaceutical Statistics, EarlyView.
      PubDate: 2022-06-27T01:24:01-07:00
      DOI: 10.1002/pst.2251
       
  • A semi‐mechanistic dose‐finding design in oncology using
           pharmacokinetic/pharmacodynamic modeling

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      Authors: Xiao Su; Yisheng Li, Peter Müller, Chia‐Wei Hsu, Haitao Pan, Kim‐Anh Do
      Abstract: Pharmaceutical Statistics, EarlyView.
      PubDate: 2022-06-24T01:44:37-07:00
      DOI: 10.1002/pst.2249
       
  • A MCP‐Mod approach to designing and analyzing survival trials with
           potential non‐proportional hazards

    • Free pre-print version: Loading...

      Authors: Xiaodong Luo; Yuan Sun, Zhixing Xu
      Abstract: Pharmaceutical Statistics, EarlyView.
      PubDate: 2022-06-23T03:59:52-07:00
      DOI: 10.1002/pst.2241
       
  • Propensity score matching and stratification using multiparty data without
           pooling

    • Free pre-print version: Loading...

      Authors: Jixian Wang; Roland Marion‐Gallois
      Abstract: Pharmaceutical Statistics, EarlyView.
      PubDate: 2022-06-22T10:54:35-07:00
      DOI: 10.1002/pst.2250
       
  • Weighted log‐rank test to compare two survival functions in the presence
           of dependent censoring

    • Free pre-print version: Loading...

      Authors: Philippe Flandre
      Abstract: Pharmaceutical Statistics, EarlyView.
      PubDate: 2022-06-16T04:03:56-07:00
      DOI: 10.1002/pst.2245
       
  • Confirmatory efficacy testing for individual dose–placebo comparisons
           using serial gatekeeping procedure in dose‐finding trials with multiple
           comparison procedures–modeling

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      Authors: Yusuke Yamaguchi; Toshifumi Sugitani, Satoshi Yoshida, Kazushi Maruo
      Abstract: Pharmaceutical Statistics, EarlyView.
      PubDate: 2022-06-16T02:54:20-07:00
      DOI: 10.1002/pst.2246
       
  • Estimation of treatment effects in short‐term depression studies. An
           evaluation based on the ICH E9(R1) estimands framework

    • Free pre-print version: Loading...

      Authors: Marian Mitroiu; Steven Teerenstra, Katrien Oude Rengerink, Frank Pétavy, Kit C. B. Roes
      Abstract: Pharmaceutical Statistics, EarlyView.
      PubDate: 2022-06-09T05:42:54-07:00
      DOI: 10.1002/pst.2214
       
  • Optimal unplanned design modification in adaptive two‐stage trials

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      Authors: Maximilian Pilz; Carolin Herrmann, Geraldine Rauch, Meinhard Kieser
      Abstract: Pharmaceutical Statistics, EarlyView.
      PubDate: 2022-05-23T09:00:31-07:00
      DOI: 10.1002/pst.2228
       
  • Statistical methodology for highly variable compounds: A novel design
           approach for the Ofatumumab Phase 2 bioequivalence study

    • Free pre-print version: Loading...

      Authors: Byron Jones; Bingbing Li, Morten Bagger, Alex Goodyear, Inga Ludwig
      Abstract: Pharmaceutical Statistics, EarlyView.
      PubDate: 2022-05-23T08:10:16-07:00
      DOI: 10.1002/pst.2233
       
  • Empirical likelihood inference for area under the receiver operating
           characteristic curve using ranked set samples

    • Free pre-print version: Loading...

      Authors: Chul Moon; Xinlei Wang, Johan Lim
      Abstract: Pharmaceutical Statistics, EarlyView.
      PubDate: 2022-05-20T04:28:53-07:00
      DOI: 10.1002/pst.2230
       
  • Standard and reference‐based conditional mean imputation

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      Authors: Marcel Wolbers; Alessandro Noci, Paul Delmar, Craig Gower‐Page, Sean Yiu, Jonathan W. Bartlett
      Abstract: Pharmaceutical Statistics, EarlyView.
      PubDate: 2022-05-19T03:28:44-07:00
      DOI: 10.1002/pst.2234
       
  • The utilities and pitfalls of stratified analysis in challenging
           situations

    • Free pre-print version: Loading...

      Authors: Jin Wang
      Abstract: Pharmaceutical Statistics, EarlyView.
      PubDate: 2022-05-16T06:22:53-07:00
      DOI: 10.1002/pst.2232
       
  • 2 stage subgroup‐specific time‐to‐event (2S‐Sub‐TITE): An
           adaptive two‐stage time‐to‐toxicity design for subgroup‐specific
           dose finding in phase I oncology trials

    • Free pre-print version: Loading...

      Authors: Alana McGovern; Andrew G. Chapple, Clement Ma
      Abstract: Pharmaceutical Statistics, EarlyView.
      PubDate: 2022-05-12T11:59:53-07:00
      DOI: 10.1002/pst.2231
       
  • A Bayesian latent class model for predicting gestational age in health
           administrative data

    • Free pre-print version: Loading...

      Authors: Shuang Wang; Gavino Puggioni, Xuerong Wen
      Abstract: Pharmaceutical Statistics, EarlyView.
      PubDate: 2022-05-10T05:00:29-07:00
      DOI: 10.1002/pst.2225
       
  • Practical guide to sample size calculations: Installation of the app
           SampSize

    • Free pre-print version: Loading...

      Authors: Laura Flight; Steven A. Julious
      Abstract: Pharmaceutical Statistics, EarlyView.
      PubDate: 2022-05-10T03:34:43-07:00
      DOI: 10.1002/pst.2215
       
  • Doubly‐robust methods for differences in restricted mean lifetimes using
           pseudo‐observations

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      Authors: Sangbum Choi; Taehwa Choi, Hye‐Young Lee, Sung Won Han, Dipankar Bandyopadhyay
      Abstract: Pharmaceutical Statistics, EarlyView.
      PubDate: 2022-05-07T02:54:57-07:00
      DOI: 10.1002/pst.2223
       
  • A flexible mixed data model applied to claims data for post‐market
           surveillance of prescription drug safety behavior

    • Free pre-print version: Loading...

      Authors: Harris Butler; John D. Rice, Nichole E. Carlson, Elaine H. Morrato
      Abstract: Pharmaceutical Statistics, EarlyView.
      PubDate: 2022-04-03T08:37:42-07:00
      DOI: 10.1002/pst.2213
       
  • Eliciting judgements about dependent quantities of interest: The SHeffield
           ELicitation Framework extension and copula methods illustrated using an
           asthma case study

    • Free pre-print version: Loading...

      Authors: Björn Holzhauer; Lisa V. Hampson, John Paul Gosling, Björn Bornkamp, Joseph Kahn, Markus R. Lange, Wen‐Lin Luo, Caterina Brindicci, David Lawrence, Steffen Ballerstedt, Anthony O'Hagan
      Abstract: Pharmaceutical Statistics, EarlyView.
      PubDate: 2022-04-03T06:28:14-07:00
      DOI: 10.1002/pst.2212
       
  • Treatment‐specific marginal structural Cox model for the effect of
           treatment discontinuation

    • Free pre-print version: Loading...

      Authors: Dana Johnson; Karen Pieper, Shu Yang
      Abstract: Pharmaceutical Statistics, EarlyView.
      PubDate: 2022-03-31T03:09:47-07:00
      DOI: 10.1002/pst.2211
       
  • Confidence intervals for point‐of‐stabilization of content
           uniformity

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      Authors: Zdeněk Hlávka; Petr Míchal, Martin Otava
      Abstract: Pharmaceutical Statistics, EarlyView.
      PubDate: 2022-03-28T05:18:27-07:00
      DOI: 10.1002/pst.2207
       
  • Geometric approaches to assessing the numerical feasibility for conducting
           matching‐adjusted indirect comparisons

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      Authors: Ekkehard Glimm; Lillian Yau
      Abstract: Pharmaceutical Statistics, EarlyView.
      PubDate: 2022-03-28T04:02:42-07:00
      DOI: 10.1002/pst.2210
       
  • SCI: A Bayesian adaptive phase I/II dose‐finding design accounting for
           semi‐competing risks outcomes for immunotherapy trials

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      Authors: Yifei Zhang; Beibei Guo, Sha Cao, Chi Zhang, Yong Zang
      Abstract: Pharmaceutical Statistics, EarlyView.
      PubDate: 2022-03-24T10:57:57-07:00
      DOI: 10.1002/pst.2209
       
  • A two‐stage adaptive clinical trial design with data‐driven subgroup
           identification at interim analysis

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      Authors: Sarah E. Johnston; Ilya Lipkovich, Alex Dmitrienko, Yan Daniel Zhao
      Abstract: Pharmaceutical Statistics, EarlyView.
      PubDate: 2022-03-24T01:39:17-07:00
      DOI: 10.1002/pst.2208
       
  • Assessment of pharmacokinetic linearity after repeated drug administration

    • Free pre-print version: Loading...

      Authors: Alexander Bauer; Matts Kagedal, Martin J. Wolfsegger
      Abstract: Pharmaceutical Statistics, EarlyView.
      PubDate: 2022-03-17T04:26:15-07:00
      DOI: 10.1002/pst.2206
       
  • The importance of using ordinal scores for patient classification based on
           health‐related quality of life trajectories

    • Free pre-print version: Loading...

      Authors: Antoine Barbieri; Florence Cousson‐Gélie, Louise Baussard, Sophie Gourgou, Christian Lavergne, Caroline Mollevi
      Abstract: Pharmaceutical Statistics, EarlyView.
      PubDate: 2022-03-15T04:43:17-07:00
      DOI: 10.1002/pst.2205
       
  • Bayesian adaptive randomization design incorporating propensity
           score‐matched historical controls

    • Free pre-print version: Loading...

      Authors: Ryo Sawamoto; Koji Oba, Yutaka Matsuyama
      Abstract: Pharmaceutical Statistics, EarlyView.
      PubDate: 2022-03-12T03:45:24-08:00
      DOI: 10.1002/pst.2203
       
  • Analysis of an incomplete binary outcome dichotomized from an underlying
           continuous variable in clinical trials

    • Free pre-print version: Loading...

      Authors: Chenchen Ma; Xin Shen, Yongming Qu, Yu Du
      Abstract: Pharmaceutical Statistics, EarlyView.
      PubDate: 2022-03-11T08:18:30-08:00
      DOI: 10.1002/pst.2204
       
  • Estimating survival parameters under conditionally independent left
           truncation

    • Free pre-print version: Loading...

      Authors: Arjun Sondhi
      Abstract: Pharmaceutical Statistics, EarlyView.
      PubDate: 2022-03-09T03:51:12-08:00
      DOI: 10.1002/pst.2202
       
  • Pairwise joint modeling of clustered and high‐dimensional outcomes with
           covariate missingness in pediatric pneumonia care

    • Free pre-print version: Loading...

      Authors: Susan Gachau; Edmund Njeru Njagi, Geert Molenberghs, Nelson Owuor, Rachel Sarguta, Mike English, Philip Ayieko
      Abstract: Pharmaceutical Statistics, EarlyView.
      PubDate: 2022-02-24T03:30:03-08:00
      DOI: 10.1002/pst.2197
       
  • Estimation and expected sample size in Simon's two stage designs that stop
           as early as possible

    • Free pre-print version: Loading...

      Authors: Antonios Daletzakis; Rutger Bor, Marianne A. Jonker, Kit C. B. Roes, Harm Tinteren
      Abstract: Pharmaceutical Statistics, EarlyView.
      PubDate: 2022-02-22T12:10:40-08:00
      DOI: 10.1002/pst.2200
       
  • Sample size re‐estimation for response‐adaptive randomized
           clinical trials

    • Free pre-print version: Loading...

      Authors: Xin Li; Feifang Hu
      Abstract: Pharmaceutical Statistics, EarlyView.
      PubDate: 2022-02-22T04:02:37-08:00
      DOI: 10.1002/pst.2199
       
  • Utilizing restricted mean duration of response for efficacy evaluation of
           cancer treatments

    • Free pre-print version: Loading...

      Authors: Bo Huang; Lu Tian
      Abstract: Pharmaceutical Statistics, EarlyView.
      PubDate: 2022-02-21T08:48:47-08:00
      DOI: 10.1002/pst.2198
       
  • Incorporating historical controls in clinical trials with longitudinal
           outcomes using the modified power prior

    • Free pre-print version: Loading...

      Authors: Hongchao Qi; Dimitris Rizopoulos, Emmanuel Lesaffre, Joost Rosmalen
      Abstract: Pharmaceutical Statistics, EarlyView.
      PubDate: 2022-02-06T09:48:53-08:00
      DOI: 10.1002/pst.2195
       
  • Estimands in observational studies: Some considerations beyond ICH E9 (R1)

    • Free pre-print version: Loading...

      Authors: Heng Li; Chenguang Wang, Wei‐Chen Chen, Nelson Lu, Changhong Song, Ram Tiwari, Yunling Xu, Lilly Q. Yue
      Abstract: Pharmaceutical Statistics, EarlyView.
      PubDate: 2022-02-06T08:58:06-08:00
      DOI: 10.1002/pst.2196
       
 
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