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Journal of Biopharmaceutical Statistics
Journal Prestige (SJR): 1.294  Citation Impact (citeScore): 1 Number of Followers: 17  Hybrid journal (It can contain Open Access articles)ISSN (Print) 1054-3406 - ISSN (Online) 1520-5711 Published by Taylor and Francis  [2652 journals]
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- Referees for Volume 33
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Pages: i - v
Abstract: Volume 33, Issue 6, November 2023
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Citation: Journal of Biopharmaceutical Statistics
PubDate: 2023-11-01T07:49:14Z
DOI: 10.1080/10543406.2023.2261738
Issue No: Vol. 33, No. 6 (2023)
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- Providing meaningful interpretation of performance outcome measures by
co-calibration with patient-reported outcomes through the Rasch model:
illustration with multiple sclerosis measures-
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Authors: Antoine RegnaultJuliette MeunierAnna CieslukWenting ChengBing Zhua Modus Outcomes; Lyon, Franceb Biogen, Cambridge, Massachusetts, USA
Pages: 1 - 21
Abstract: .
Citation: Journal of Biopharmaceutical Statistics
PubDate: 2023-11-26T08:13:52Z
DOI: 10.1080/10543406.2023.2280557
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- Adaptive platform trials: the impact of common controls on type one error
and power-
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Authors: Quynh NguyenKatharina HeesBenjamin Hofnera Section Data Science; Epidemiology, Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU), Erlangen, Germany
Pages: 1 - 18
Abstract: .
Citation: Journal of Biopharmaceutical Statistics
PubDate: 2023-11-22T06:02:09Z
DOI: 10.1080/10543406.2023.2275765
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- Meaningful within-patient change for clinical outcome assessments:
model-based approach versus cumulative distribution functions-
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Authors: Jinma RenAndrew G. BushmakinPaul R. CisloLucy AbrahamJoseph C. CappelleriRobert H. DworkinJohn T. Farrara Statistical Research & Data Science Center; Pfizer Inc, Collegeville, Pennsylvania, USAb Statistical Research & Data Science Center, Pfizer Inc, Groton, Connecticut, USAc Statistical Research & Data Science Center, Pfizer Inc, New York, New York, USAd Global Access & Value, Pfizer Ltd, Tadworth, Kent, UKe Department of Anesthesiology Biostatistics, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, USA
Pages: 1 - 13
Abstract: .
Citation: Journal of Biopharmaceutical Statistics
PubDate: 2023-11-20T01:36:40Z
DOI: 10.1080/10543406.2023.2281575
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- Reflections on estimands for patient-reported outcomes in cancer clinical
trials-
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Authors: Rachael LawranceKonstantina SkaltsaAntoine RegnaultLysbeth Flodena Members of the EFSPI/PSI Estimands in Oncology Special Interest Group; PRO Task Forceb Adelphi Values Ltd, Macclesfield, UKc IQVIA, Barcelona, Spaind Modus Outcomes, Lyon, Francee Clinical Outcome Solutions, Tuscon, USA
Pages: 1 - 11
Abstract: .
Citation: Journal of Biopharmaceutical Statistics
PubDate: 2023-11-19T05:54:48Z
DOI: 10.1080/10543406.2023.2280628
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- A composite semiparametric homogeneity test for the distributions of
multigroup interval-bounded longitudinal data-
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Authors: Zhanfeng WangWenmei LiHao DingDongsheng Tua Department of Statistics; Technology of China, Hefei, Anhui, Chinab Canadian Cancer Trials Group, Queen’s University, Kingston, Ontario, Canada
Pages: 1 - 12
Abstract: .
Citation: Journal of Biopharmaceutical Statistics
PubDate: 2023-11-16T06:50:19Z
DOI: 10.1080/10543406.2023.2275769
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- Enhancement of Bayesian optimal interval design by accounting for overdose
and underdose errors trade-offs-
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Authors: Ryo SadachiHiroyuki SatoTakeo FujiwaraAkihiro Hirakawaa Biostatistics Division; Center for Research Administration Dental University, Tokyo, Japan
Pages: 1 - 20
Abstract: .
Citation: Journal of Biopharmaceutical Statistics
PubDate: 2023-11-15T01:08:16Z
DOI: 10.1080/10543406.2023.2275766
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- Covariate-adjusted value-guided subgroup identification via boosting
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Authors: Jinchun ZhangPingye ZhangJunshui MaYue Shentua Merck & Co. MRL; BARDS, Rahway, New Jersey, USAb Gilead Sciences Inc, Foster City, California, USA
Pages: 1 - 18
Abstract: .
Citation: Journal of Biopharmaceutical Statistics
PubDate: 2023-11-13T01:52:11Z
DOI: 10.1080/10543406.2023.2275757
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- Adjusted win ratio using the inverse probability of treatment weighting
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Authors: Duolao WangSirui ZhengYing CuiNengjie HeTao ChenBo Huanga Biostatistics Unit; Department of Clinical Sciences, Liverpool School of Tropical Medicine, Pembroke, UKb Department of Biostatistics Bioinformatics, Emory University, Atlanta, Georgia, USAc Centre for Health Economics, University of York, York, UKd Pfizer Research & Development, Pfizer Inc, Groton, Connecticut, USA
Pages: 1 - 16
Abstract: .
Citation: Journal of Biopharmaceutical Statistics
PubDate: 2023-11-10T01:42:46Z
DOI: 10.1080/10543406.2023.2275759
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- Novel 3-arm wait-list controlled trial designs together with mixed-effects
analysis improve precision of treatment effect estimators-
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Authors: Xiangmei MaYin Bun Cheunga Centre for Quantitative Medicine; Duke-NUS Medical School, Singapore, Singaporeb Programme in Health Services & Systems Research, Duke-NUS Medical School, Singapore, Singaporec Tampere Center for Child, Adolescent Maternal Health Research, Tampere University, Tampere, Finland
Pages: 1 - 15
Abstract: .
Citation: Journal of Biopharmaceutical Statistics
PubDate: 2023-11-06T10:44:56Z
DOI: 10.1080/10543406.2023.2275755
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- Response to letter to the editor – comment on “emerging insights and
commentaries – MMRM vs LOCF by Naitee Ting”-
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Authors: Naitee TingBiostatistics; Data Sciences, Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, Connecticut USA
Pages: 1 - 2
Abstract: .
Citation: Journal of Biopharmaceutical Statistics
PubDate: 2023-11-01T05:53:05Z
DOI: 10.1080/10543406.2023.2267648
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- Multiple test procedures of disease prevalence based on stratified
partially validated series in the presence of a gold standard-
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Authors: Shi-Fang QiuXiao-Liang ZhangYing-Qiu QuYuan-Quan Hana Department of Statistics; Economics, Chongqing, China
Pages: 1 - 22
Abstract: .
Citation: Journal of Biopharmaceutical Statistics
PubDate: 2023-10-19T07:10:56Z
DOI: 10.1080/10543406.2023.2269262
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- Estimation of treatment effects in early-phase randomized clinical trials
involving external control data-
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Authors: Heiko GötteMarietta KirchnerJohannes KrisamArthur AllignolArmin SchülerMeinhard Kiesera Global Biostatistics; Merck Healthcare KGaA, Darmstadt, Germanyb Institute of Medical Biometry, University of Heidelberg, Heidelberg, Germanyc HTA Medical Affairs, Daiichi Sankyo Europe GmbH, Munich, Germany
Pages: 1 - 20
Abstract: .
Citation: Journal of Biopharmaceutical Statistics
PubDate: 2023-10-12T10:06:48Z
DOI: 10.1080/10543406.2023.2256835
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- The impact of misclassification errors on the performance of biomarkers
based on next-generation sequencing, a simulation study-
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Authors: Dong WangSue-Jane WangSamir Lababidia Division of Bioinformatics; Research, Office of Digital Transformation, Office of Commissioner, FDA, Maryland, USA
Pages: 1 - 19
Abstract: .
Citation: Journal of Biopharmaceutical Statistics
PubDate: 2023-10-11T12:32:55Z
DOI: 10.1080/10543406.2023.2269251
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- Response to Comment on ”Emerging insights and commentaries – MMRM vs
LOCF by Naitee Ting”-
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Authors: David WrightDaniel J. BrattonThomas DruryOliver N. KeeneSunita RehalIan R. Whitea Statistical Innovation; Data Science & Artificial Intelligence, Biopharmaceuticals R&D, AstraZeneca, Cambridge, UKb Statistics Data Science Innovation Hub, GSK, London, UKc KeeneONStatisticsd MRC Clinical Trials Unit at UCL, University College London
Pages: 1 - 3
Abstract: .
Citation: Journal of Biopharmaceutical Statistics
PubDate: 2023-09-25T12:04:47Z
DOI: 10.1080/10543406.2023.2250853
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- Whole-cage randomization for animal studies with unequal cage or group
sizes-
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Authors: Tianhui ZhangBenjamin PhillipsNatasha KarpJunmin WangSteven Novicka Data Sciences; Quantitative Biology, Discovery Sciences, Biopharmaceuticals R&D, AstraZeneca, Cambridge, UKc Dynamic Omics, Center for Genomics Research, Biopharmaceuticals R&D, AstraZeneca, Gaithersburg, Maryland, USA
Pages: 1 - 11
Abstract: .
Citation: Journal of Biopharmaceutical Statistics
PubDate: 2023-09-19T11:55:42Z
DOI: 10.1080/10543406.2023.2256834
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- CORRECTION
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Pages: 1 - 2
Abstract: .
Citation: Journal of Biopharmaceutical Statistics
PubDate: 2023-09-16T11:35:55Z
DOI: 10.1080/10543406.2023.2258646
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- Bayesian hierarchical model for dose-finding trial incorporating
historical data-
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Authors: Linxi HanQiqi DengZhangyi HeFrank FleischerFeng Yua School of Mathematics; University of Bristol, Bristol, UKb Biostatistics Biostatistics, School of Public Health, Imperial College London, London, UKd Biostatistics+Data Sciences Corp, Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany
Pages: 1 - 15
Abstract: .
Citation: Journal of Biopharmaceutical Statistics
PubDate: 2023-09-07T12:54:52Z
DOI: 10.1080/10543406.2023.2251578
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- On variance estimation of target population created by inverse probability
weighting-
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Authors: Jinmei ChenRui ChenYuhao FengMing TanPingyan ChenYing Wua Department of Biostatistics; School of Public Health, Southern Medical University, Guangzhou, Chinab Hainan Institute of Real World Data, The Administration of Boao Lecheng International Medical Tourism Pilot Zone, Hainan, Chinac Department of Biology, School of Life Sciences, Hainan University, Haikou, Chinad Department of Biostatistics, Bioinformatics Biomathematics, Georgetown University, Washington, United States
Pages: 1 - 19
Abstract: .
Citation: Journal of Biopharmaceutical Statistics
PubDate: 2023-08-25T06:19:45Z
DOI: 10.1080/10543406.2023.2244593
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- Stochastic curtailment tests for phase II trial with time-to-event outcome
using the concept of relative time in the case of non-proportional hazards
-
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Authors: Palash SharmaMilind A. PhadnisDepartment of Biostatistics & Data Science; University of Kansas Medical Center, Kansas City, Kansas, USA
Pages: 1 - 16
Abstract: .
Citation: Journal of Biopharmaceutical Statistics
PubDate: 2023-08-14T07:28:37Z
DOI: 10.1080/10543406.2023.2244056
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- Determining the late effect parameter in the Fleming-Harrington test using
asymptotic relative efficiency in cancer immunotherapy clinical trials-
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Authors: Yuichiro KanekoSatoshi Moritaa Department of Biomedical Statistics; Bioinformatics, Kyoto University Graduate School of Medicine, Kyoto, Japanb Data Science Statistical & RWD Science, Astellas Pharma Global Development Inc, Northbrook, Illinois, USA
Pages: 1 - 20
Abstract: .
Citation: Journal of Biopharmaceutical Statistics
PubDate: 2023-08-10T10:58:29Z
DOI: 10.1080/10543406.2023.2244055
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- Pediatric needs should be considered early in the clinical development
lifecycle-
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Authors: Margaret GamaloJingjing YeYounJeong ChoiRima Izem
Pages: 1 - 4
Abstract: .
Citation: Journal of Biopharmaceutical Statistics
PubDate: 2023-08-08T02:01:48Z
DOI: 10.1080/10543406.2023.2235841
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- Sample size reestimation and Bayesian predictive probability for
single-arm clinical trials with a time-to-event endpoint using Weibull
distribution with unknown shape parameter-
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Authors: Muhammad WaleedJianghua HeMilind A. Phadnisa Biostatistics; Research Decision Sciences, Merck & Co, Inc, North Wales, Pennsylvania, United Statesb Department of Biostatistics & Data Science, University of Kansas Medical Center, Kansas City, Kansas, United States
Pages: 1 - 19
Abstract: .
Citation: Journal of Biopharmaceutical Statistics
PubDate: 2023-08-07T06:03:30Z
DOI: 10.1080/10543406.2023.2234998
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- Special Issue PRO-Analysis of Clinically Meaningful Change on
Patient-Reported Outcomes: Renewed Insights About Covariate Adjustment-
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Authors: Joseph C. CappelleriPaul R. CisloStatistical Research; Data Science Center, Pfizer Inc, Groton, Connecticut, USA
Pages: 1 - 14
Abstract: .
Citation: Journal of Biopharmaceutical Statistics
PubDate: 2023-08-01T01:08:18Z
DOI: 10.1080/10543406.2023.2237115
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- Adaptive Multiple Comparison Sequential Design (AMCSD) for clinical trials
-
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Authors: Ping GaoYingqiu Lia Innovatio Statistics; Inc., Bridgewater, New Jersey, USAb School of Mathematics Technology, Changsha, Hunan, China
Pages: 1 - 17
Abstract: .
Citation: Journal of Biopharmaceutical Statistics
PubDate: 2023-08-01T01:00:11Z
DOI: 10.1080/10543406.2023.2233590
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- Simulating survival data when one subgroup lacks information
-
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Authors: Yiqi ZhaoPing YanXinfeng Yanga Guangzhou Culture; Programming, Jiangsu Hengrui Medicine Co., Ltd., Lianyungang, P.R. China
Pages: 1 - 13
Abstract: .
Citation: Journal of Biopharmaceutical Statistics
PubDate: 2023-07-27T05:15:50Z
DOI: 10.1080/10543406.2023.2236218
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- Incorporating patient-reported outcomes in dose-finding clinical trials
with continuous patient enrollment-
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Authors: Anaïs AndrillonLucie BiardShing M. Leea INSERM U1153 Team ECSTRRA; Université Paris Cité, Paris, Franceb Department of Statistical Methodology, Saryga, Tournus, Francec Department of Biostatistics, Mailman School of Public Health, Columbia University, New York, New York, USA
Pages: 1 - 12
Abstract: .
Citation: Journal of Biopharmaceutical Statistics
PubDate: 2023-07-27T05:09:49Z
DOI: 10.1080/10543406.2023.2236216
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- Direct estimation of volume under the ROC surface with verification bias
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Authors: Shuangfei ShiGengsheng QinDepartment of Mathematics; Statistics, Georgia State University, Atlanta, USA
Pages: 1 - 29
Abstract: .
Citation: Journal of Biopharmaceutical Statistics
PubDate: 2023-07-20T12:21:44Z
DOI: 10.1080/10543406.2023.2236202
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- A Bayesian phase I–II clinical trial design to find the biological
optimal dose on drug combination-
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Authors: Ziqing WangJingyi ZhangTian XiaRuyue HeFangrong YanResearch Center of Biostatistics; Computational Pharmacy, China Pharmaceutical University, Nanjing, P.R. China
Pages: 1 - 14
Abstract: .
Citation: Journal of Biopharmaceutical Statistics
PubDate: 2023-07-18T06:44:24Z
DOI: 10.1080/10543406.2023.2236208
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- A new type of generalized information criterion for regularization
parameter selection in penalized regression with application to treatment
process data-
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Authors: Amir Hossein GhatariMina AminghafariDepartment of Statistics; Faculty of Mathematics Computer Science, Amirkabir University of Technology, Tehran, Iran
Pages: 1 - 25
Abstract: .
Citation: Journal of Biopharmaceutical Statistics
PubDate: 2023-07-17T07:42:56Z
DOI: 10.1080/10543406.2023.2228399
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- Group sequential multi-arm multi-stage survival trial design with
treatment selection-
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Authors: Jianrong WuYimei Lia Biostatistics Shared Resource Facility; University of New Mexico Comprehensive Cancer Center, Albuquerque, New Mexico, United Statesb Department of Biostatistics, St. Jude Children’s Research Hospital, Memphis, Tennessee, United States
Pages: 1 - 16
Abstract: .
Citation: Journal of Biopharmaceutical Statistics
PubDate: 2023-07-17T05:14:43Z
DOI: 10.1080/10543406.2023.2235409
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- Two-stage response adaptive randomization designs for multi-arm trials
with binary outcome-
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Authors: Xinlin LuGuogen ShanDepartment of Biostatistics; University of Florida, Gainesville, Florida, USA
Pages: 1 - 13
Abstract: .
Citation: Journal of Biopharmaceutical Statistics
PubDate: 2023-07-15T02:42:05Z
DOI: 10.1080/10543406.2023.2234028
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- Statistical Considerations and Software for Designing Sequential, Multiple
Assignment, Randomized Trials (SMART) with a Survival Final Endpoint-
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Authors: Sasha KravetsAmy S. RuppertSawyer B. JacobsonJennifer G. Le-RademacherSumithra J. Mandrekara Division of Epidemiology; Company, Indianapolis, Indiana, USAc Division of Hematology, Ohio State University, Columbus, Ohio, USAd Department of Advanced Analytics & Data Science,C.H. Rob Inson, Eden Prairie, Minnesota, USAe Department of Quantitative Health Sciences, Mayo Clinic, Rochester, Minnesota, USA
Pages: 1 - 14
Abstract: .
Citation: Journal of Biopharmaceutical Statistics
PubDate: 2023-07-12T06:25:01Z
DOI: 10.1080/10543406.2023.2233616
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- Using Bayesian hierarchical models for controlled post hoc subgroup
analysis of clinical trials: application to smoking cessation treatment in
American Indians and Alaska Natives-
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Authors: Elena SherginaKimber P. RichterChristine Makosky DaleyBabalola FaseruWon S. ChoiByron J. Gajewskia Department of Biostatistics & Data Science; University of Kansas Cancer Center, Kansas City, Kansas, USAb Department of Population Health, University of Kansas Medical Center, Kansas City, Kansas, USAc Department of Community Health Population, Lehigh University, Bethlehem, Pennsylvania, USA
Pages: 1 - 13
Abstract: .
Citation: Journal of Biopharmaceutical Statistics
PubDate: 2023-07-07T01:32:23Z
DOI: 10.1080/10543406.2023.2233598
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- Statistical considerations for some issues in clinical bridging studies
evaluating companion diagnostic devices-
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Authors: Changhong SongXiaoqin XiongSunghee KimZhiheng XuDandan XuBipasa BiswasDivision of Biostatistics; Center for Devices Drug Administration, Silver Spring, Maryland, USA
Pages: 1 - 12
Abstract: .
Citation: Journal of Biopharmaceutical Statistics
PubDate: 2023-06-18T07:40:14Z
DOI: 10.1080/10543406.2023.2220398
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- Generalized exponentiated unit Gompertz distribution for modeling
arthritic pain relief times data: classical approach to statistical
inference-
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Authors: Tabassum Naz SindhuAnum ShafiqZawar Huassiana Department of Statistics; Quaid-i-Azam University, Islamabad, Pakistanb School of Mathematics Technology, Nanjing, Chinac Department of Statistics, Faculty of Computing, The Islamia University of Bahawalpur, Bahawalpur, Pakistan
Pages: 1 - 26
Abstract: .
Citation: Journal of Biopharmaceutical Statistics
PubDate: 2023-05-29T01:37:03Z
DOI: 10.1080/10543406.2023.2210681
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- Dissecting the restricted mean time in favor of treatment
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Authors: Lu MaoTuo WangDepartment of Biostatistics; Public Health, University of Wisconsin-Madison, Madison, WI, USA
Pages: 1 - 16
Abstract: .
Citation: Journal of Biopharmaceutical Statistics
PubDate: 2023-05-24T05:42:08Z
DOI: 10.1080/10543406.2023.2210658
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- Applying latent profile analysis to identify adolescents and young adults
with chronic conditions at risk for poor health-related quality of life-
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Authors: Suwei WangCara J. ArizmendiDandan ChenLi LinDan V. BlalockI-Chan HuangDavid ThissenDarren A. DeWaltWei PanBryce B. Reevea Center for Health Measurement; Department of Population Health Sciences, Duke University School of Medicine, Durham, North Carolina, USAb Department of Psychiatry Analytics in the School of Nursing, Duke University, Durham, North Carolina, USAh Department of Pediatrics, Duke University School of Medicine, Durham, North Carolina, USA
Pages: 1 - 14
Abstract: .
Citation: Journal of Biopharmaceutical Statistics
PubDate: 2023-05-15T05:20:41Z
DOI: 10.1080/10543406.2023.2210684
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- scRAA: the development of a robust and automatic annotation procedure for
single-cell RNA sequencing data-
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Authors: Dongyan YanZhe SunJiyuan FangShanshan CaoWenjie WangXinyue ChangSarkhan BadirliHaoda FuYushi Liua Global Statistical Science; Eli Lilly & Co, Indianapolis, Indiana, USAb Advance Analytics Data Science, Eli Lilly & Co, Indianapolis, Indiana, USA
Pages: 1 - 14
Abstract: .
Citation: Journal of Biopharmaceutical Statistics
PubDate: 2023-05-10T01:17:44Z
DOI: 10.1080/10543406.2023.2208671
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- Epistemic uncertainty in Bayesian predictive probabilities
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Authors: Charles C. LiuRon Xiaolong YuDepartment of Biostatistics; Gilead Sciences, Foster City, CA, USA
Pages: 1 - 19
Abstract: .
Citation: Journal of Biopharmaceutical Statistics
PubDate: 2023-05-09T06:38:28Z
DOI: 10.1080/10543406.2023.2204943
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- Robust time selection for interim analysis in the Bayesian phase 2
exploratory clinical trial-
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Authors: Bo FengBenny ZeeDivision of Biostatistics; Jockey Club School of Public Health Primary Care, The Chinese University of Hong Kong, HKSAR, China
Pages: 1 - 11
Abstract: .
Citation: Journal of Biopharmaceutical Statistics
PubDate: 2023-05-05T09:51:14Z
DOI: 10.1080/10543406.2023.2208665
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- Estimation of median survival time and its 95% confidence interval using
SAS PROC LIFETEST-
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Authors: Paul A. TalsmaStatistics Department; Vivos Technology Limited (Phastar), London, UK
Pages: 1 - 13
Abstract: .
Citation: Journal of Biopharmaceutical Statistics
PubDate: 2023-05-05T09:43:17Z
DOI: 10.1080/10543406.2023.2206481
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- Optimal biological dose selection in dose-finding trials with
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Authors: Yusuke YamaguchiKentaro TakedaSatoshi YoshidaKazushi Maruoa Astellas Pharma Global Development; Inc, Northbrook, Illinois, USAb Data Science, Astellas Pharma Inc, Tokyo, Japanc Department of Biostatistics, University of Tsukuba, Tsukuba, Japan
Pages: 1 - 15
Abstract: .
Citation: Journal of Biopharmaceutical Statistics
PubDate: 2023-04-28T01:22:43Z
DOI: 10.1080/10543406.2023.2202259
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- Non-inferiority trials with time-to-event data: clarifying the impact of
censoring-
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Authors: Jaeun ChoiXiaonan XueMimi KimDepartment of Epidemiology; Population Health, Albert Einstein College of Medicine, New York, New York, USA
Pages: 1 - 18
Abstract: .
Citation: Journal of Biopharmaceutical Statistics
PubDate: 2023-04-12T01:18:25Z
DOI: 10.1080/10543406.2023.2194391
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- Quantile regression shrinkage and selection via the Lqsso
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Authors: Alireza DaneshvarMousa GolalizadehDepartment of Statistics; Tarbiat Modares University, Tehran, Iran
Pages: 1 - 26
Abstract: .
Citation: Journal of Biopharmaceutical Statistics
PubDate: 2023-04-10T04:34:13Z
DOI: 10.1080/10543406.2023.2198593
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- Assessing the incidence and severity of drug adverse events: a Bayesian
hierarchical cumulative logit model-
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Authors: Jiawei DuanByron J. GajewskiParamita SenJo A. Wicka Global Drug Development; Novartis Pharmaceuticals Corporation, 1 Health Plaza, East Hanover, New Jersey, USAb Department of Biostatistics & Data Science, University of Kansas Medical Center, Kansas, USA
Pages: 1 - 20
Abstract: .
Citation: Journal of Biopharmaceutical Statistics
PubDate: 2023-04-05T05:45:35Z
DOI: 10.1080/10543406.2023.2194385
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- A confirmatory basket design considering non-inferiority and superiority
testing-
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Authors: Yaohua ZhangChenghao ChuRobert A. BeckmanLei GaoGlen LairdBingming Yia Department of Biometrics; Vertex Pharmaceuticals Inc, Boston, Massachusetts, USAb Departments of Oncology Programming, Moderna, Cambridge, Massachusetts, USA
Pages: 1 - 17
Abstract: .
Citation: Journal of Biopharmaceutical Statistics
PubDate: 2023-03-29T01:24:54Z
DOI: 10.1080/10543406.2023.2192781
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- Simple methods for comparing two predictive values with incomplete data
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Authors: Yougui WuCollege of Public Health; University of South Florida, Tampa, Florida, USA
Pages: 1 - 16
Abstract: .
Citation: Journal of Biopharmaceutical Statistics
PubDate: 2023-03-20T12:57:31Z
DOI: 10.1080/10543406.2023.2188925
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- Correction
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Pages: 1 - 1
Abstract: .
Citation: Journal of Biopharmaceutical Statistics
PubDate: 2023-03-20T06:34:23Z
DOI: 10.1080/10543406.2023.2189357
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- Improved confidence estimation for the binomial proportion with
applications to clinical studies-
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Authors: Mo YangXiaoning KangBorek Puzaa School of Finance; Dongbei University of Finance Economics, Dalian, Liaoning, Chinac Research School of Finance, Actuarial Studies & Statistics, The Australian National University, Canberra, Australia
Pages: 1 - 15
Abstract: .
Citation: Journal of Biopharmaceutical Statistics
PubDate: 2023-03-16T02:35:38Z
DOI: 10.1080/10543406.2023.2183506
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- A win ratio-based framework to combine multiple clinical endpoints in
exploratory basket trials-
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Authors: Pingye ZhangXiaoyun (Nicole) LiGlobal Statistics; Data Science, BeiGene, Ltd, Ridgefield Park, New Jersey, USA
Pages: 1 - 9
Abstract: .
Citation: Journal of Biopharmaceutical Statistics
PubDate: 2023-03-09T06:25:52Z
DOI: 10.1080/10543406.2023.2187819
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- Step-down multiple testing procedures for the overall population and
partitioning subgroups-
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Authors: John LawrenceOffice of Biostatistics; US Food Drug Administration, Silver Spring, Maryland,USA
Pages: 1 - 11
Abstract: .
Citation: Journal of Biopharmaceutical Statistics
PubDate: 2023-03-08T05:48:02Z
DOI: 10.1080/10543406.2023.2187818
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- A Bayesian joint model for multivariate longitudinal and time-to-event
data with application to ALL maintenance studies-
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Authors: Damitri KunduPartha SarkarManash Pratim GogoiKiranmoy Dasa Applied Statistics Division; Indian Statistical Institute, Kolkata, Indiab Department of Statistics, University of Florida, Gainesville, Florida, USAc Tata Translational Cancer Research Centre, Tata Medical Center, Kolkata, India
Pages: 1 - 18
Abstract: .
Citation: Journal of Biopharmaceutical Statistics
PubDate: 2023-03-08T05:44:07Z
DOI: 10.1080/10543406.2023.2187413
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- Propensity score stratified MAP prior and posterior inference for
incorporating information across multiple potentially heterogeneous data
sources-
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Authors: Angela Yaqian ZhuDooti RoyZheng ZhuMartin Oliver Sailera Statistics; Data Science, Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany
Pages: 1 - 15
Abstract: .
Citation: Journal of Biopharmaceutical Statistics
PubDate: 2023-03-08T05:42:54Z
DOI: 10.1080/10543406.2023.2181354
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- Dose-finding based on feasibility and late-onset toxicity in adoptive cell
therapy trials-
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Authors: Evan M. BagleyNolan A. Wagesa Department of Statistics; University of Virginia, Charlottesville, VA, USAb Department of Biostatistics, Virginia Commonwealth University, Richmond, VA, USA
Pages: 1 - 13
Abstract: .
Citation: Journal of Biopharmaceutical Statistics
PubDate: 2023-03-07T06:11:55Z
DOI: 10.1080/10543406.2023.2183507
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- Estimation of the selected treatment mean in two stage drop-the-losers
design-
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Authors: MasihuddinNeeraj MisraDepartment of Mathematics & Statistics; Indian Institute of Technology Kanpur, Kanpur, Uttar Pradesh, India
Pages: 1 - 26
Abstract: .
Citation: Journal of Biopharmaceutical Statistics
PubDate: 2023-03-06T05:00:51Z
DOI: 10.1080/10543406.2023.2183962
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- Weighted log-rank tests for censored data under Wei’s urn design:
saddlepoint approximation and confidence intervals-
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Authors: Abd El-Raheem M. Abd El-RaheemEhab F. Abd-ElfattahDepartment of Mathematics; Faculty of Education, Ain Shams University, Cairo, Egypt
Pages: 1 - 10
Abstract: .
Citation: Journal of Biopharmaceutical Statistics
PubDate: 2023-03-03T01:51:41Z
DOI: 10.1080/10543406.2023.2183508
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- Assessment of nonlinear dose–response relationships via
nonparametric regression-
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Authors: Shunyao WuQi ZhangYuanzhang LiHua Lianga Department of Computer Science; Technology, Qingdao University, Shandong, Qingdao, Chinab Department of Statistics, George Washington University, DC, Washington, USA
Pages: 1 - 10
Abstract: .
Citation: Journal of Biopharmaceutical Statistics
PubDate: 2023-03-02T01:40:25Z
DOI: 10.1080/10543406.2023.2183505
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- Use of Bayesian decision analysis to maximize value in patient-centered
randomized clinical trials in Parkinson’s disease-
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Authors: Shomesh E. ChaudhuriZied Ben ChaouchBrett HauberBrennan MangeMo ZhouStephanie ChristopherDawn BardotMargaret SheehanAnne DonnellyLauren McLaughlinBrittany CaldwellHeather L. BenzMartin HoAnindita SahaKatrina GwinnMurray SheldonAndrew W. Loa Laboratory for Financial Engineering; MIT Sloan School of Management, Cambridge, MA, USAb Electrical Engineering Artificial Intelligence Laboratory, MIT, Cambridge, MA, USAj Santa Fe Institute, Santa Fe, NM, USA
Pages: 1 - 20
Abstract: .
Citation: Journal of Biopharmaceutical Statistics
PubDate: 2023-03-02T01:38:35Z
DOI: 10.1080/10543406.2023.2170400
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- Extent of safety database in pediatric drug development: types of
assessment, analytical precision, and pathway for extrapolation through
on-target effects-
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Authors: Margaret GamaloYihua ZhaoAijun GaoJingjing YeJunjing LinEiji EshidaYounJeong ChoiRobert Nelsona Pfizer; Collegeville, PA, USAb Flatiron Health, New York, NY, USAc Alexion Pharmaceuticals, Boston, MA, USAd BeiGene, Cambridge, MA, USAe Takeda Pharmaceuticals, Cambridge, MA, USAf Sunovion, Great Falls, VA, USAg Roche/Genentech, San Francisco, CA, USAh Johnson & Johnson, Spring House, PA, USA
Pages: 1 - 16
Abstract: .
Citation: Journal of Biopharmaceutical Statistics
PubDate: 2023-02-27T05:33:48Z
DOI: 10.1080/10543406.2023.2172425
-
- A Bayesian joint model for multivariate longitudinal and time-to-event
data with application to ALL maintenance studies-
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Authors: Damitri KunduPartha SarkarKiranmoy Dasa Applied Statistics Division; Indian Statistical Institute, Kolkata, Indiab Department of Statistics, University of Florida, Gainesville, Florida, USA
Pages: 1 - 18
Abstract: .
Citation: Journal of Biopharmaceutical Statistics
PubDate: 2023-02-10T12:30:21Z
DOI: 10.1080/10543406.2023.2171430
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- Reverse graphical approaches for multiple test procedures
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Authors: Jiangtao GouDepartment of Mathematics; Statistics, Villanova University, Villanova, PA, USA
Pages: 1 - 21
Abstract: .
Citation: Journal of Biopharmaceutical Statistics
PubDate: 2023-02-09T01:57:47Z
DOI: 10.1080/10543406.2023.2171428
-
- Recent Use of Pediatric Extrapolation in Pediatric Drug Development in US
-
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Authors: Jingjing YeVickie ZhangFoteini StrimenopoulouYihua ZhaoHaitao PanMayadah ShabboutMargaret Gamaloa Global Statistics; Data Sciences (GSDS), BeiGene, Fulton, MD, USAb Global Biometrics, Servier Pharmaceuticals, Boston, Massachusetts, USAc Centre for Excellence in Statistical Innovation (CESI), UCB Pharma, UKd Quantitative Sciences, Flatiron Health, Inc, New York, NYe Department of Biostatistics, St. Jude Children’s Research Hospital, Memphis, TN, USAf Biostatistics, GlaxoSmithKline, Collegeville, PA, USAg Pfizer Inc, New York, NY, USA
Pages: 1 - 15
Abstract: .
Citation: Journal of Biopharmaceutical Statistics
PubDate: 2023-02-08T05:19:30Z
DOI: 10.1080/10543406.2023.2170407
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- Clinical trial considerations for pediatric cancer drug development
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Authors: Freda CoonerJingjing YeGregory Reamana Global Biostatistics; Amgen Inc, Thousand Oaks, CA, USAb Global Statistics Data Sciences (GSDS), BeiGene USA, Fulton, MD, USAc Oncology Center of Excellence, Office of the Commissioner, U.S. FDA, Silver Spring, MD, USA
Pages: 1 - 16
Abstract: .
Citation: Journal of Biopharmaceutical Statistics
PubDate: 2023-02-07T01:58:46Z
DOI: 10.1080/10543406.2023.2172424
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- Group sequential designs for cancer immunotherapy trial with delayed
treatment effect-
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Authors: Jianrong WuYimei LiLiang Zhua Division of Epidemiology; Biostatistics, Preventive Medicine, University of New Mexico, Albuquerque, NM, USAb Department of Biostatistics, St. Jude Children’s Research Hospital, Memphis, TNc Internal Medicine, University of Texas Health Science Center, Houston, TX, USA
Pages: 1 - 15
Abstract: .
Citation: Journal of Biopharmaceutical Statistics
PubDate: 2023-02-06T05:27:20Z
DOI: 10.1080/10543406.2023.2170403
-
- A promising subgroup identification method based on a genetic algorithm
for censored survival data-
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Authors: Liang ZhaoWenjie ZhangYing WuLei CaoLiuying WangKang Lia Department of Epidemiology; Biostatistics, Public Health School, Harbin Medical University, Harbin, Heilongjiang, Chinab Department of Biostatistics, School of Public Health, Southern Medical University, Guangzhou, Guangdong, China
Pages: 1 - 23
Abstract: .
Citation: Journal of Biopharmaceutical Statistics
PubDate: 2023-02-02T07:37:02Z
DOI: 10.1080/10543406.2023.2170397
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- P-values and confidence intervals of linear rank tests for left-truncated
data under truncated binomial design-
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Authors: Abd El-Raheem M. Abd El-RaheemKholoud S. KamalEhab F. Abd-ElfattahDepartment of Mathematics; Faculty of Education, Ain Shams University, Cairo, Egypt
Pages: 1 - 9
Abstract: .
Citation: Journal of Biopharmaceutical Statistics
PubDate: 2023-01-30T05:13:47Z
DOI: 10.1080/10543406.2023.2171431
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- In vitro dissolution profile comparison using bootstrap bias corrected
similarity factor, f2-
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Authors: Shaobo LiuXiaoyu CaiMeiyu ShenYi TsongDivision of Biometrics VI; Office of Biostatistics, Office of Translational Sciences, Center for Drug Evaluation Drug Administration, Silver Spring, Maryland, USA
Pages: 1 - 12
Abstract: .
Citation: Journal of Biopharmaceutical Statistics
PubDate: 2023-01-30T05:11:48Z
DOI: 10.1080/10543406.2023.2171429
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- Case study using RWD in the context of a pivotal trial for regulatory
approval in a rare disease-
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Authors: Paul O’ConnellAntonia RidolfiNathalie Fretaulta Analytics; Novartis Ireland Limited, Dublin, Irelandb Analytics, Novartis Pharma S.A.S, Rueil-Malmaison, France
Pages: 1 - 8
Abstract: .
Citation: Journal of Biopharmaceutical Statistics
PubDate: 2023-01-30T04:49:28Z
DOI: 10.1080/10543406.2023.2170406
-
- Perspectives on informative Bayesian methods in pediatrics
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Authors: James TravisMark RothmannAndrew Thomsona Office of Biostatistics; Office of Translational Science, Center for the Drug Evaluation Methods Taskforce, European Medicines Agency, Amsterdam, NL
Pages: 1 - 14
Abstract: .
Citation: Journal of Biopharmaceutical Statistics
PubDate: 2023-01-30T04:45:36Z
DOI: 10.1080/10543406.2023.2170405
-
- Random intercept hierarchical linear model for multi-regional clinical
trials-
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Authors: Chunkyun ParkSeung-Ho KangDepartment of Statistics; Data Science Department of Applied statistics, Yonsei University, Seoul, Korea
Pages: 1 - 21
Abstract: .
Citation: Journal of Biopharmaceutical Statistics
PubDate: 2023-01-30T04:43:57Z
DOI: 10.1080/10543406.2023.2170395
-
- Composite Likelihoods with Bounded Weights in Extrapolation of Data
-
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Authors: Margaret GamaloYoonji KimFan ZhangJunjing Lina Global Biometrics & Data Management; Pfizer Inc Pennsylvania, Collegeville, Pennsylvania, USAb Department of Statistics, Ohio State University, Columbus, Ohio, USAc Global Biometrics & Data Management, Pfizer Inc, Groton, Connecticut, USAd Statistical Quantitative Sciences, Takeda Pharmaceuticals, Cambridge, MA, USA
Pages: 1 - 18
Abstract: .
Citation: Journal of Biopharmaceutical Statistics
PubDate: 2023-01-20T03:48:15Z
DOI: 10.1080/10543406.2022.2152835
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- RESTART trial design: two-stage seamless transition design with
operational considerations-
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Authors: Min YiBin ZhuoFreda Coonera Arrowhead Pharmaceuticals Inc; Biostatistics, Pasadena, CA, USAb Boehringer Ingelheim (China) Investment Co. Ltd, Biostatistics, Shanghai, Chinac Amgen Inc, Global Biostatistics, Thousand Oaks, CA, USA
Pages: 1 - 10
Abstract: .
Citation: Journal of Biopharmaceutical Statistics
PubDate: 2023-01-19T04:27:22Z
DOI: 10.1080/10543406.2022.2162915
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- Advancing drug development in pediatric oncology, a focus on cancer
biology and targeted therapies: iMATRIX platform-
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Authors: Marianne UguenMagalie HiltonMufiza Farid-KapadiaAsim DatyeSaibah ChohanClaudia CarlucciMark DixonMarkus ElzeYingjia ChenKit Wun Kathy CheungRucha SaneMaoxia ZhengYounJeong Choia Data; Statistical Sciences, Genentech Inc, South San Francisco, CA, USA
Pages: 1 - 12
Abstract: .
Citation: Journal of Biopharmaceutical Statistics
PubDate: 2023-01-13T01:14:34Z
DOI: 10.1080/10543406.2022.2162071
-
- Utility of propensity score-based Bayesian borrowing of external adult
data in pediatric trials: A pragmatic evaluation through a case study in
acute lymphoblastic leukemia (ALL)-
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Authors: Antara MajumdarRebecca RothwellGregory ReamanCorinne AhlbergPourab Roya Oncology Biostatistics; GlaxoSmithKline, Collegeville, PA, USAb Office of Biostatistics, U.S. Food Drug Administration, Silver Spring, MD, USAd Acorn AI by Medidata, a Dassault Systèmes company, New York, NY, USAe Biostatistics, Regeneron Pharmaceuticals, Tarrytown, NY, USA
Pages: 1 - 15
Abstract: .
Citation: Journal of Biopharmaceutical Statistics
PubDate: 2023-01-05T04:59:15Z
DOI: 10.1080/10543406.2022.2162069
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