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Abstract: Pharmaceutical Statistics, Volume 23, Issue 4, Page 439-441, July/August 2024. PubDate: 2024-07-11T10:50:54-07:00 DOI: 10.1002/pst.2310 Issue No: Vol. 23, No. 4 (2024)
- Comparative Analyses of Bioequivalence Assessment Methods for In Vitro
Permeation Test Data-
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Authors:
Sami Leon; Elena Rantou,
Jessica Kim,
Sungwoo Choi,
Nam Hee Choi Abstract: Pharmaceutical Statistics, EarlyView. PubDate: 2024-08-24T05:15:17-07:00 DOI: 10.1002/pst.2434
- Simultaneous Inference Using Multiple Marginal Models
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Authors:
Ludwig A. Hothorn; Christian Ritz,
Frank Schaarschmidt,
Signe M. Jensen,
Robin Ristl Abstract: Pharmaceutical Statistics, EarlyView. PubDate: 2024-08-21T12:06:33-07:00 DOI: 10.1002/pst.2428
- Sample Size Reestimation in Stochastic Curtailment Tests With
Time‐to‐Events Outcome in the Case of Nonproportional Hazards Utilizing Two Weibull Distributions With Unknown Shape Parameters-
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Palash Sharma; Milind A. Phadnis Abstract: Pharmaceutical Statistics, EarlyView. PubDate: 2024-08-18T07:29:58-07:00 DOI: 10.1002/pst.2429
- Bayesian Predictive Probability Based on a Bivariate Index Vector for
Single‐Arm Phase II Study With Binary Efficacy and Safety Endpoints-
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Authors:
Takuya Yoshimoto; Satoru Shinoda,
Kouji Yamamoto,
Kouji Tahata Abstract: Pharmaceutical Statistics, EarlyView. PubDate: 2024-08-13T11:11:08-07:00 DOI: 10.1002/pst.2431
- Principles for Defining Estimands in Clinical Trials—A Proposal
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Authors:
Tobias Mütze; James Bell,
Stefan Englert,
Philip Hougaard,
Dan Jackson,
Vivian Lanius,
Henrik Ravn Abstract: Pharmaceutical Statistics, EarlyView. PubDate: 2024-08-13T10:19:38-07:00 DOI: 10.1002/pst.2432
- A Personalized Dose‐Finding Algorithm Based on Adaptive Gaussian
Process Regression-
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Authors:
Yeonhee Park; Won Chang Abstract: Pharmaceutical Statistics, EarlyView. PubDate: 2024-08-09T03:47:47-07:00 DOI: 10.1002/pst.2417
- Bayesian Methods for Quality Tolerance Limit (QTL) Monitoring
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Authors:
J. C. Poythress; Jin Hyung Lee,
Kentaro Takeda,
Jun Liu Abstract: Pharmaceutical Statistics, EarlyView. PubDate: 2024-08-09T03:43:23-07:00 DOI: 10.1002/pst.2427
- Applying the Estimand Framework to Non‐Inferiority Trials
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Authors:
Helle Lynggaard; Oliver N. Keene,
Tobias Mütze,
Sunita Rehal Abstract: Pharmaceutical Statistics, EarlyView. PubDate: 2024-08-08T04:13:36-07:00 DOI: 10.1002/pst.2433
- Tutorial on Firth's Logistic Regression Models for Biomarkers in
Preclinical Space-
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Gina D'Angelo; Di Ran Abstract: Pharmaceutical Statistics, EarlyView. PubDate: 2024-08-06T11:38:49-07:00 DOI: 10.1002/pst.2422
- Mixture Experimentation in Pharmaceutical Formulations: A Tutorial
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Authors:
Lynne B. Hare; Stan Altan,
Hans Coppenolle Abstract: Pharmaceutical Statistics, EarlyView. PubDate: 2024-08-05T11:18:46-07:00 DOI: 10.1002/pst.2426
- Estimation of Treatment Policy Estimands for Continuous Outcomes Using
Off‐Treatment Sequential Multiple Imputation-
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Authors:
Thomas Drury; Juan J. Abellan,
Nicky Best,
Ian R. White Abstract: Pharmaceutical Statistics, EarlyView. PubDate: 2024-08-04T11:08:41-07:00 DOI: 10.1002/pst.2411
- Efficient Study Design and Analysis of Longitudinal Dose–Response Data
Using Fractional Polynomials-
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Benjamin F. Hartley; Dave Lunn,
Adrian P. Mander Abstract: Pharmaceutical Statistics, EarlyView. PubDate: 2024-07-28T05:34:40-07:00 DOI: 10.1002/pst.2425
- Strategy for Designing In Vivo Dose–Response Comparison Studies
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Steven Novick; Tianhui Zhang Abstract: Pharmaceutical Statistics, EarlyView. PubDate: 2024-07-17T12:09:15-07:00 DOI: 10.1002/pst.2421
- Sample Size Estimation Using a Partially Clustered Frailty Model for
Biomarker‐Strategy Designs With Multiple Treatments-
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Derek Dinart; Virginie Rondeau,
Carine Bellera Abstract: Pharmaceutical Statistics, EarlyView. PubDate: 2024-07-16T10:40:46-07:00 DOI: 10.1002/pst.2407
- Handling Partially Observed Trial Data After Treatment Withdrawal:
Introducing Retrieved Dropout Reference‐Base Centred Multiple Imputation -
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Authors:
Suzie Cro; James H. Roger,
James R. Carpenter Abstract: Pharmaceutical Statistics, EarlyView. PubDate: 2024-07-16T04:49:42-07:00 DOI: 10.1002/pst.2416
- Reparametrized Firth's Logistic Regressions for Dose‐Finding Study With
the Biased‐Coin Design-
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Authors:
Hyungwoo Kim; Seungpil Jung,
Yudi Pawitan,
Woojoo Lee Abstract: Pharmaceutical Statistics, EarlyView. PubDate: 2024-07-16T04:29:28-07:00 DOI: 10.1002/pst.2423
- Bayesian Hierarchical Models for Subgroup Analysis
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Authors:
Yun Wang; Wenda Tu,
William Koh,
James Travis,
Robert Abugov,
Kiya Hamilton,
Mengjie Zheng,
Roberto Crackel,
Pablo Bonangelino,
Mark Rothmann Abstract: Pharmaceutical Statistics, EarlyView. PubDate: 2024-07-15T10:55:51-07:00 DOI: 10.1002/pst.2424
- Variable Duration Trial as an Alternative Design for Continuous Endpoints
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Jitendra Ganju; Julie Guoguang Ma Abstract: Pharmaceutical Statistics, EarlyView. PubDate: 2024-07-11T10:04:44-07:00 DOI: 10.1002/pst.2418
- The Role of CMC Statisticians: Co‐Practitioners of the Scientific
Method-
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Timothy Schofield
Abstract: Pharmaceutical Statistics, EarlyView. PubDate: 2024-07-10T07:14:28-07:00 DOI: 10.1002/pst.2420
- Exploring Stratification Strategies for Population‐ Versus
Randomization‐Based Inference-
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Marco Novelli; William F. Rosenberger Abstract: Pharmaceutical Statistics, EarlyView. PubDate: 2024-07-10T04:42:18-07:00 DOI: 10.1002/pst.2419
- Potency Assay Variability Estimation in Practice
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Authors:
Hang Li; Tomasz M. Witkos,
Scott Umlauf,
Christopher Thompson Abstract: Pharmaceutical Statistics, EarlyView. PubDate: 2024-07-08T11:01:13-07:00 DOI: 10.1002/pst.2408
- Survival Analysis Without Sharing of Individual Patient Data by Using a
Gaussian Copula-
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Federico Bonofiglio
Abstract: Pharmaceutical Statistics, EarlyView. PubDate: 2024-07-07T09:24:37-07:00 DOI: 10.1002/pst.2415
- Optimal Cut‐Point Selection Methods Under Binary Classification When
Subclasses Are Involved-
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Jia Wang; Lili Tian Abstract: Pharmaceutical Statistics, EarlyView. PubDate: 2024-07-07T05:51:38-07:00 DOI: 10.1002/pst.2413
- Futility Interim Analysis Based on Probability of Success Using a
Surrogate Endpoint-
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Authors:
Ronan Fougeray; Loïck Vidot,
Marco Ratta,
Zhaoyang Teng,
Donia Skanji,
Gaëlle Saint‐Hilary Abstract: Pharmaceutical Statistics, EarlyView. PubDate: 2024-07-02T08:48:33-07:00 DOI: 10.1002/pst.2410
- T3 + 3: 3 + 3 Design With Delayed Outcomes
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Authors:
Jiaying Guo; Mengyi Lu,
Isabella Wan,
Yumin Wang,
Leng Han,
Yong Zang Abstract: Pharmaceutical Statistics, EarlyView. PubDate: 2024-06-25T10:15:04-07:00 DOI: 10.1002/pst.2414
- Investigating Stability in Subgroup Identification for Stratified Medicine
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Authors:
G. M. Hair; T. Jemielita,
S. Mt‐Isa,
P. M. Schnell,
R. Baumgartner Abstract: Pharmaceutical Statistics, EarlyView. PubDate: 2024-06-25T09:49:19-07:00 DOI: 10.1002/pst.2409
- To Dilute or Not to Dilute: Nominal Titer Dosing for Genetic Medicines
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Paul Faya; Tianhui Zhang Abstract: Pharmaceutical Statistics, EarlyView. PubDate: 2024-06-25T09:49:08-07:00 DOI: 10.1002/pst.2406
- Do You Want to Stay Single' Considerations on Single‐Arm Trials in Drug
Development and the Postregulatory Space-
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Authors:
Yulia Dyachkova; Cornelia Dunger‐Baldauf,
Nathalie Barbier,
Jenny Devenport,
Stefan Franzén,
Gbenga Kazeem,
Thomas Künzel,
Pierre Mancini,
Giacomo Mordenti,
Knut Richert,
Antonia Ridolfi,
Daniel Saure Abstract: Pharmaceutical Statistics, EarlyView. PubDate: 2024-06-25T09:48:45-07:00 DOI: 10.1002/pst.2412
- The partnership between statisticians and the Institutional Animal Care
and Use Committee (IACUC)-
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Authors:
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 Abstract: Pharmaceutical Statistics, EarlyView. PubDate: 2024-06-11T04:44:06-07:00 DOI: 10.1002/pst.2390
- Experimental design considerations and statistical analyses in preclinical
tumor growth inhibition studies-
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Authors:
Vinicius Bonato; Szu‐Yu Tang,
Matilda Hsieh,
Yao Zhang,
Shibing Deng Abstract: Pharmaceutical Statistics, EarlyView. PubDate: 2024-06-10T06:19:31-07:00 DOI: 10.1002/pst.2399
- 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-
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Leandro Garcia Barrado; Tomasz Burzykowski Abstract: Pharmaceutical Statistics, EarlyView. PubDate: 2024-06-05T03:43:24-07:00 DOI: 10.1002/pst.2398
- A model‐assisted design for partially or completely ordered groups
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Connor Celum; Mark Conaway Abstract: Pharmaceutical Statistics, EarlyView. PubDate: 2024-05-20T11:59:51-07:00 DOI: 10.1002/pst.2396
- Covariate adjustment and estimation of difference in proportions in
randomized clinical trials-
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Jialuo Liu; Dong Xi Abstract: Pharmaceutical Statistics, EarlyView. PubDate: 2024-05-19T07:49:19-07:00 DOI: 10.1002/pst.2397
- Visualizing hypothesis tests in survival analysis under anticipated
delayed effects-
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Authors:
José L. Jiménez; Isobel Barrott,
Francesca Gasperoni,
Dominic Magirr Abstract: Pharmaceutical Statistics, EarlyView. PubDate: 2024-05-06T02:19:50-07:00 DOI: 10.1002/pst.2393
- Current developments of the estimand concept
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Alexander Fierenz; Antonia Zapf Abstract: Pharmaceutical Statistics, EarlyView. PubDate: 2024-04-27T02:04:04-07:00 DOI: 10.1002/pst.2395
- Optimal sample size division in two‐stage seamless designs
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Authors:
Lindsay R. Berry; Joe Marion,
Scott M. Berry,
Kert Viele Abstract: Pharmaceutical Statistics, EarlyView. PubDate: 2024-04-27T01:48:39-07:00 DOI: 10.1002/pst.2394
- Comments on ‘standard and reference‐based conditional mean
imputation’: Regulators and trial statisticians be aware!-
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Authors:
Suzie Cro; Tim P. Morris,
James H. Roger,
James R. Carpenter Abstract: Pharmaceutical Statistics, EarlyView. PubDate: 2024-04-17T04:38:26-07:00 DOI: 10.1002/pst.2373
- Rejoinder to the letter: “Standard and reference‐based conditional
mean imputation: Regulators and trial statisticians be aware!”-
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Authors:
Marcel Wolbers; Alessandro Noci,
Paul Delmar,
Sean Yiu,
Jonathan W. Bartlett Abstract: Pharmaceutical Statistics, EarlyView. PubDate: 2024-04-17T04:38:20-07:00 DOI: 10.1002/pst.2374
- Comparing various Bayesian random‐effects models for pooling randomized
controlled trials with rare events-
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Authors:
Minghong Yao; Yulong Jia,
Fan Mei,
Yuning Wang,
Kang Zou,
Ling Li,
Xin Sun Abstract: Pharmaceutical Statistics, EarlyView. PubDate: 2024-04-16T11:30:04-07:00 DOI: 10.1002/pst.2392
- Tree‐temporal scan statistics for safety signal detection in vaccine
clinical trials-
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François Haguinet; Fabian Tibaldi,
Christophe Dessart,
Andrew Bate Abstract: Pharmaceutical Statistics, EarlyView. PubDate: 2024-04-15T10:03:47-07:00 DOI: 10.1002/pst.2391
- Mathematical programming tools for randomization purposes in small
two‐arm clinical trials: A case study with real data-
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Alan R. Vazquez; Weng‐Kee Wong Abstract: Pharmaceutical Statistics, EarlyView. PubDate: 2024-04-13T01:46:40-07:00 DOI: 10.1002/pst.2388
- Predictive Ppk calculations for biologics and vaccines using a Bayesian
approach – a tutorial-
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Jos Weusten; Jianfang Hu Abstract: Pharmaceutical Statistics, EarlyView. PubDate: 2024-04-11T12:15:15-07:00 DOI: 10.1002/pst.2380
- Dynamic borrowing of historical controls adjusting for covariates in
vaccine efficacy clinical trials-
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Andrea Callegaro; Yongyi Luo,
Naveen Karkada,
Toufik Zahaf Abstract: Pharmaceutical Statistics, EarlyView. PubDate: 2024-04-09T03:18:10-07:00 DOI: 10.1002/pst.2384
- Information‐based group sequential design for post‐market safety
monitoring of medical products using real world data-
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Zhiwei Zhang; Carrie Nielson,
Ching‐Yi Chuo,
Zhishen Ye Abstract: Pharmaceutical Statistics, EarlyView. PubDate: 2024-04-08T01:20:57-07:00 DOI: 10.1002/pst.2385
- Balance diagnostics in propensity score analysis following multiple
imputation: A new method-
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Sevinc Puren Yucel Karakaya; Ilker Unal Abstract: Pharmaceutical Statistics, EarlyView. PubDate: 2024-04-05T11:34:32-07:00 DOI: 10.1002/pst.2389
- A practical guide to the appropriate analysis of eGFR data over time: A
simulation study-
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Todd DeVries; Kevin J. Carroll,
Sandra A. Lewis Abstract: Pharmaceutical Statistics, EarlyView. PubDate: 2024-04-03T07:58:35-07:00 DOI: 10.1002/pst.2381
- Synergy detection: A practical guide to statistical assessment of
potential drug combinations-
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Elli Makariadou; Xuechen Wang,
Nicholas Hein,
Negera W. Deresa,
Kathy Mutambanengwe,
Bie Verbist,
Olivier Thas Abstract: Pharmaceutical Statistics, EarlyView. PubDate: 2024-04-02T12:04:05-07:00 DOI: 10.1002/pst.2383
- Effects of sceptical priors on the performance of adaptive clinical trials
with binary outcomes.-
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Authors:
Anders Granholm; Theis Lange,
Michael O. Harhay,
Anders Perner,
Morten Hylander Møller,
Benjamin Skov Kaas‐Hansen Abstract: Pharmaceutical Statistics, EarlyView. PubDate: 2024-03-29T08:35:10-07:00 DOI: 10.1002/pst.2387
- Time‐to‐event estimands and loss to follow‐up in oncology in light
of the estimands guidance-
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Authors:
Jonathan M. Siegel; Hans‐Jochen Weber,
Stefan Englert,
Feng Liu,
Michelle Casey, on behalf of the Pharmaceutical Industry Working Group on Estimands in Oncology Abstract: Pharmaceutical Statistics, EarlyView. PubDate: 2024-03-29T08:29:01-07:00 DOI: 10.1002/pst.2386
- Simulation‐based sample size calculations of marginal proportional means
models for recurrent events with competing risks-
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Authors:
Julie Funch Furberg; Per Kragh Andersen,
Thomas Scheike,
Henrik Ravn Abstract: Pharmaceutical Statistics, EarlyView. PubDate: 2024-03-20T08:29:40-07:00 DOI: 10.1002/pst.2382
- Statistical approaches to evaluate in vitro dissolution data against
proposed dissolution specifications-
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Authors:
Fasheng Li; Beverly Nickerson,
Les Van Alstine,
Ke Wang Abstract: Pharmaceutical Statistics, EarlyView. PubDate: 2024-03-17T12:00:00-07:00 DOI: 10.1002/pst.2379
- Optimal sample size allocation for two‐arm superiority and
non‐inferiority trials with binary endpoints-
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Marietta Kirchner; Stefanie Schüpke,
Meinhard Kieser Abstract: Pharmaceutical Statistics, EarlyView. PubDate: 2024-03-12T05:55:32-07:00 DOI: 10.1002/pst.2375
- Estimation of the odds ratio from multi‐stage randomized trials
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Shiwei Cao; Sin‐Ho Jung Abstract: Pharmaceutical Statistics, EarlyView. PubDate: 2024-03-10T06:50:07-07:00 DOI: 10.1002/pst.2378
- A propensity score‐integrated approach for leveraging external data in a
randomized controlled trial with time‐to‐event endpoints-
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Authors:
Wei‐Chen Chen; Nelson Lu,
Chenguang Wang,
Heng Li,
Changhong Song,
Ram Tiwari,
Yunling Xu,
Lilly Q. Yue Abstract: Pharmaceutical Statistics, EarlyView. PubDate: 2024-03-05T05:10:00-08:00 DOI: 10.1002/pst.2377
- Digital twins and Bayesian dynamic borrowing: Two recent approaches for
incorporating historical control data-
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Authors:
Carl‐Fredrik Burman; Erik Hermansson,
David Bock,
Stefan Franzén,
David Svensson Abstract: Pharmaceutical Statistics, EarlyView. PubDate: 2024-03-04T08:49:35-08:00 DOI: 10.1002/pst.2376
- Sample size calculation for comparing two ROC curves
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Sin‐Ho Jung
Abstract: Pharmaceutical Statistics, EarlyView. PubDate: 2024-02-28T04:01:00-08:00 DOI: 10.1002/pst.2371
- What they forgot to tell you about machine learning with an application to
pharmaceutical manufacturing-
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Kjell Johnson; Max Kuhn Abstract: Pharmaceutical Statistics, EarlyView. PubDate: 2024-02-28T02:32:55-08:00 DOI: 10.1002/pst.2366
- Shrinkage priors for isotonic probability vectors and binary data
modeling, with applications to dose–response modeling-
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Authors:
Philip S. Boonstra; Daniel R. Owen,
Jian Kang Abstract: Pharmaceutical Statistics, EarlyView. PubDate: 2024-02-23T11:00:48-08:00 DOI: 10.1002/pst.2372
- On sample size calculation in drug interaction trials
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Paul Meyvisch; Mitra Ebrahimpoor Abstract: Pharmaceutical Statistics, EarlyView. PubDate: 2024-02-14T09:49:10-08:00 DOI: 10.1002/pst.2367
- Introduction to qualification and validation of an immunoassay
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Sarah Janssen
Abstract: Pharmaceutical Statistics, EarlyView. PubDate: 2024-02-13T08:19:38-08:00 DOI: 10.1002/pst.2370
- Assessing the performance of group‐based trajectory modeling method to
discover different patterns of medication adherence-
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Authors:
Awa Diop; Alind Gupta,
Sabrina Mueller,
Louis Dron,
Ofir Harari,
Heather Berringer,
Vinusha Kalatharan,
Jay J. H. Park,
Miceline Mésidor,
Denis Talbot Abstract: Pharmaceutical Statistics, EarlyView. PubDate: 2024-02-08T12:24:15-08:00 DOI: 10.1002/pst.2365
- Predicting subgroup treatment effects for a new study: Motivations,
results and learnings from running a data challenge in a pharmaceutical corporation-
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Authors:
Björn Bornkamp; Silvia Zaoli,
Michela Azzarito,
Ruvie Martin,
Carsten Philipp Müller,
Conor Moloney,
Giulia Capestro,
David Ohlssen,
Mark Baillie Abstract: Pharmaceutical Statistics, EarlyView. PubDate: 2024-02-07T09:07:18-08:00 DOI: 10.1002/pst.2368
- On the relative conservativeness of Bayesian logistic regression method in
oncology dose‐finding studies-
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Cheng‐Han Yang; Guanghui Cheng,
Ruitao Lin Abstract: Pharmaceutical Statistics, EarlyView. PubDate: 2024-02-05T12:00:00-08:00 DOI: 10.1002/pst.2364
- A case study: Assessing the efficacy of the revised dosage regimen via
prediction model for recurrent event rate using biomarker data-
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Ahrim Youn; Jiarui Chi,
Yue Cui,
Hui Quan Abstract: Pharmaceutical Statistics, EarlyView. PubDate: 2024-02-05T09:54:18-08:00 DOI: 10.1002/pst.2362
- A generalized Bayesian optimal interval design for dose optimization in
immunotherapy-
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Authors:
Qing Xia; Kentaro Takeda,
Yusuke Yamaguchi,
Jun Zhang Abstract: Pharmaceutical Statistics, EarlyView. PubDate: 2024-01-31T04:09:04-08:00 DOI: 10.1002/pst.2369
- The flaw of averages: Bayes factors as posterior means of the likelihood
ratio-
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Charles C. Liu; Ron Xiaolong Yu,
Murray Aitkin Abstract: Pharmaceutical Statistics, EarlyView. PubDate: 2024-01-28T06:24:05-08:00 DOI: 10.1002/pst.2355
- Transporting randomized trial results to estimate counterfactual survival
functions in target populations-
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Authors:
Zhiqiang Cao; Youngjoo Cho,
Fan Li Abstract: Pharmaceutical Statistics, EarlyView. PubDate: 2024-01-17T06:05:02-08:00 DOI: 10.1002/pst.2354
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