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检索条件"机构=Biostat and Programming"
416 条 记 录,以下是141-150 订阅
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Two-stage stratified designs with survival outcomes and adjustment for misclassification in predictive biomarkers
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STATISTICS IN MEDICINE 2024年 第10期43卷 1883-1904页
作者: Chen, Yanping Lin, Yong Lu, Shou-En Shih, Weichung J. Quan, Hui Bristol Myers Squibb Dept Biostat Berkeley Hts NJ USA Rutgers State Univ Sch Publ Hlth Biostat & Epidemiol Dept Piscataway NJ USA Rutgers Canc Inst New Jersey Biometr Div New Brunswick NJ USA Sanofi Biostat & Programming Bridgewater NJ USA Rutgers State Univ Sch Publ Hlth Biostat & Epidemiol Dept 683 Hoes Lane WestRM 214 Piscataway NJ 08854 USA
Biomarker stratified clinical trial designs are versatile tools to assess biomarker clinical utility and address its relationship with clinical endpoints. Due to imperfect assays and/or classification rules, biomarker... 详细信息
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Approaches to handling data when a phase II trial deviates from the pre-specified Simon's two-stage design
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STATISTICS IN MEDICINE 2008年 第29期27卷 6190-6208页
作者: Wu, Yujun Shih, Weichung J. Univ Med & Dent New Jersey Canc Inst New Jersey Sch Publ Hlth Dept Biostat Piscataway NJ 08854 USA Univ Med & Dent New Jersey Canc Inst New Jersey Div Biometr Piscataway NJ 08854 USA Sanofi Aventis Dept Biostat & Programming Bridgewater NJ USA
Simon's 'optimal' and 'minimax' two-stage designs are common methods for conducting phase IIA studies investigating new cancer therapies. However. these designs are rather rigid in their settings b... 详细信息
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Hypothesis tests for stratified mark-specific proportional hazards models with missing covariates, with application to HIV vaccine efficacy trials
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BIOMETRICAL JOURNAL 2018年 第3期60卷 516-536页
作者: Sun, Yanqing Qi, Li Yang, Guangren Gilbert, Peter B. Univ North Carolina Charlotte Dept Math & Stat Charlotte NC 28223 USA Sanofi Biostat & Programming Bridgewater MA 08807 USA Jinan Univ Sch Econ Dept Stat Guangzhou Guangdong Peoples R China Univ Washington Dept Biostat Seattle WA 98109 USA Fred Hutchinson Canc Res Ctr Seattle WA 98109 USA
This article develops hypothesis testing procedures for the stratified mark-specific proportional hazards model with missing covariates where the baseline functions may vary with strata. The mark-specific proportional... 详细信息
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Mark-specific additive hazards regression with continuous marks
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LIFETIME DATA ANALYSIS 2017年 第3期23卷 467-494页
作者: Han, Dongxiao Sun, Liuquan Sun, Yanqing Qi, Li Chinese Acad Sci Inst Appl Math Beijing 100190 Peoples R China Univ North Carolina Charlotte Dept Math & Stat Charlotte NC 28223 USA Sanofi Biostat & Programming Bridgewater NJ 08807 USA
For survival data, mark variables are only observed at uncensored failure times, and it is of interest to investigate whether there is any relationship between the failure time and the mark variable. The additive haza... 详细信息
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Analysis of generalized semiparametric mixed varying-coefficients models for longitudinal data
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CANADIAN JOURNAL OF STATISTICS-REVUE CANADIENNE DE STATISTIQUE 2019年 第3期47卷 352-373页
作者: Sun, Yanqing Qi, Li Heng, Fei Gilbert, Peter B. Univ North Carolina Charlotte Dept Math & Stat Charlotte NC 28223 USA Sanofi Biostat & Programming Bridgewater NJ 08807 USA Univ Washington Dept Biostat Seattle WA 98195 USA Fred Hutchinson Canc Res Ctr Stat Ctr HIV AIDS Res & Prevent Seattle WA 98109 USA
The generalized semiparametric mixed varying-coefficient effects model for longitudinal data can accommodate a variety of link functions and flexibly model different types of covariate effects, including time-constant... 详细信息
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Evaluation of Normalization Methods To Predict CYP3A4 Induction in Six Fully Characterized Cryopreserved Human Hepatocyte Preparations and HepaRG Cells
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DRUG METABOLISM AND DISPOSITION 2016年 第1期44卷 50-60页
作者: Vermet, Helene Raoust, Nathalie Ngo, Robert Essermeant, Luc Klieber, Sylvie Fabre, Gerard Boulenc, Xavier Sanofi Rech & Dev Drug Disposit Domain Disposit Safety & Anim Res S F-34184 Montpellier France Sanofi Rech & Dev Biostat & Programming Clin Sci & Operat Sci Core F-34184 Montpellier France
Prediction of drug-drug interactions due to cytochrome P450 isoform 3A4 (CYP3A4) overexpression is important because this CYP isoform is involved in the metabolism of about 30% of clinically used drugs from almost all...
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Pharmacokinetic Variability of Long-Acting Stimulants in the Treatment of Children and Adults with Attention-Deficit Hyperactivity Disorder
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CNS DRUGS 2010年 第12期24卷 1009-1025页
作者: Ermer, James C. Adeyi, Ben A. Pucci, Michael L. Shire Dev Inc Pharmaceut Sci Clin Pharmacol & Pharmacokinet Wayne PA USA Shire Dev Inc Biostat & Stat Programming Wayne PA USA Ogilvy CommonHlth Sci Commun Med Affairs Parsippany NJ USA
Methylphenidate- and amfetamine-based stimulants are first-line pharmacotherapies for attention-deficit hyperactivity disorder, a common neurobehavioural disorder in children and adults. A number of long-acting stimul... 详细信息
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An Alternative Way to Classify Missing Data Mechanism in Clinical TrialsA Dialogue on Missing Data
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JOURNAL OF BIOPHARMACEUTICAL STATISTICS 2011年 第2期21卷 355-361页
作者: Wei, Lynn Sanofi Aventis US Biostat & Programming Bridgewater NJ 08807 USA
Statisticians in pharmaceutical field are constantly challenged by missing data caused by patient dropout in clinical trials. What the targeted population parameter for statistical inference should be when missing dat... 详细信息
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The probability of observing negative subgroup results when the treatment effect is positive and homogeneous across all subgroups
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DRUG INFORMATION JOURNAL 2007年 第1期41卷 47-56页
作者: Li, Zhengqing Chuang-Stein, Christy Hoseyni, Cyrus Bristol Myers Squibb Co Global Biometr Sci Wallingford CT 06492 USA Pfizer Global Res & Dev Clin Stat Ann Arbor MI USA Wyeth Pharmaceut Global Biostat & Programming Collegeville PA USA
Subgroup analysis is an important part in the design and analysis of clinical trials. The importance arises from the scientific and commercial implications of such analysis. The predominant concerns about subgroup ana... 详细信息
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Drug-Drug Interaction Study to Assess the Effect of Cytochrome P450 Inhibition and Induction on the Pharmacokinetics of the Novel Cereblon Modulator Avadomide (CC-122) in Healthy Adult Subjects
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JOURNAL OF CLINICAL PHARMACOLOGY 2019年 第12期59卷 1620-1631页
作者: Ogasawara, Ken MacGorman, Kimberly Liu, Liangang Chen, Jian Carayannopoulos, Leonidas N. Zhou, Simon Palmisano, Maria Li, Yan Celgene Corp Translat Dev & Clin Pharmacol 556 Morris Ave Summit NJ 07901 USA Celgene Corp Biostat & Stat Programming Berkeley Hts NJ USA Celgene Corp Nonclin Dev Summit NJ USA
Avadomide (CC-122) is a novel immunomodulatory drug that binds to cereblon, a member of the Cullin 4-RING E3 ubiquitin ligase complex. Avadomide has multiple pharmacologic activities including potent immune modulation... 详细信息
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