Estimation of cancer drug potencies and relative potencies from in vitro data.

abstract：:A thorough QT trial is typically designed to test for two set of hypotheses. The primary set of hypotheses is for demonstrating that the test treatment will not prolong QT interval. The second set of hypotheses is to demonstrate the assay sensitivity of the positive control treatment in the study population. The conve...

journal_title：Journal of biopharmaceutical statistics

authors： Tsong Y

更新日期：2013-01-01 00:00:00

abstract：:Classification measures play essential roles in the assessment and construction of classifiers. Hence, determining how to prevent these measures from being affected by individual observations has become an important problem. In this paper, we propose several indexes based on the influence function and the concept of l...

journal_title：Journal of biopharmaceutical statistics

authors： Ke BS,Chiang AJ,Chang YI

更新日期：2018-01-01 00:00:00

abstract：:A test and a reference analytical method are usually compared for agreement based on paired data obtained from several independent subjects. Bias between two methods can be classified as constant and proportional. In this article, we provide an approach for maximum likelihood estimation of total bias between two metho...

journal_title：Journal of biopharmaceutical statistics

authors： Magari RT

更新日期：2004-11-01 00:00:00

abstract：:This paper addresses the problem of analyzing multivariate response with the variates having different distributions. We use the generalized estimating equations proposed by Prentice and Zhao (1) to estimate mean and covariance parameters. Wald statistics are used to test hypotheses about the parameters. Data from a t...

journal_title：Journal of biopharmaceutical statistics

authors： May WL,Johnson WD

更新日期：1996-05-01 00:00:00

abstract：:Pharmacokinetic studies of drug and metabolite concentrations in the blood are usually conducted as crossover trials, especially in phases I and II. A longitudinal series of measurements is collected on each subject within each period. However, much of the dependence among such observations, within and between periods...

journal_title：Journal of biopharmaceutical statistics

authors： Lindsey JK,Wang J,Byrom WD,Jones B

更新日期：1999-08-01 00:00:00

abstract：:A model-based approach is developed to estimate the distribution of time from seroconversion to diagnosis with acquired immunodeficiency syndrome (AIDS) as a function of selected time-dependent covariates. The approach is applied to longitudinal data collected over 4 years of follow-up from 450 men seropositive for th...

journal_title：Journal of biopharmaceutical statistics

authors： Dunlop DD,Tamhane AC,Chmiel JS,Phair JP

更新日期：1994-07-01 00:00:00

abstract：:We consider the problem of estimating a biomarker-based subgroup and testing for treatment effect in the overall population and in the subgroup after the trial. We define the best subgroup as the subgroup that maximizes the power for comparing the experimental treatment with the control. In the case of continuous outc...

journal_title：Journal of biopharmaceutical statistics

authors： Joshi N,Fine J,Chu R,Ivanova A

更新日期：2019-01-01 00:00:00

abstract：:Multiple testing problems in regulatory applications are often more challenging than the problems of handling a set of mathematical symbols representing multiple null hypotheses under testing. In the union-intersection setting, it is important to define a family of null hypotheses relevant to the clinical questions at...

journal_title：Journal of biopharmaceutical statistics

authors： Hung HM,Wang SJ

更新日期：2009-01-01 00:00:00

abstract：:In a clinical dose finding study with active control a new drug with several dose levels is compared with an active comparator drug. The main focus of such studies often lies on the estimation of a target dose that leads to the same efficacy as the control. This article investigates the finite sample properties of the...

journal_title：Journal of biopharmaceutical statistics

authors： Helms HJ,Benda N,Friede T

更新日期：2015-01-01 00:00:00

abstract：:In recent years, development of biosimilar products has attracted considerable attention. Because of the structural complexity of biologics, it is difficult to demonstrate that a biosimilar product is identical to the reference product. Therefore, for the development of biosimilar products, we need to adopt an approac...

journal_title：Journal of biopharmaceutical statistics

authors： Nagasaki M,Ando Y

更新日期：2014-01-01 00:00:00

abstract：:It is well known that there is strong relationship between HIV viral load and CD4 cell counts in AIDS studies. However, the relationship between them changes during the course of treatment and may vary among individuals. During treatments, some individuals may experience terminal events such as death. Because the term...

journal_title：Journal of biopharmaceutical statistics

authors： Lu T,Wang M,Liu G,Dong GH,Qian F

更新日期：2016-01-01 00:00:00

abstract：:Tango (Biostatistics 2016) proposed a new repeated measures design called the S:T repeated measures design, combined with generalized linear mixed-effects models and sample size calculations for a test of the average treatment effect that depend not only on the number of subjects but on the number of repeated measures...

journal_title：Journal of biopharmaceutical statistics

authors： Tango T

更新日期：2017-01-01 00:00:00

abstract：:How long a dementia patient is cared for in the home before admission to a nursing home depends on the state of the patient and the state of the caregiver. Using 5-year follow-up data, the times until entry to nursing home and until death are modeled using a Cox survival model in which patient and caregiver variables ...

journal_title：Journal of biopharmaceutical statistics

authors： McGilchrist CA,Brodaty H,Peters KE,Harris L

更新日期：1994-03-01 00:00:00

abstract：:The Log-odds ratio for 2 × 2 contingency tables is often approximated by a normal distribution with an approximated variance. Hwang and Biswas (2008) illustrated that the standard expression for the variance should be modified in the presence of correlation. They also provided an adjustment to this variance expression...

journal_title：Journal of biopharmaceutical statistics

authors： Biswas A,Hwang JS

更新日期：2011-01-01 00:00:00

abstract：:In clinical trials, it is important to set up a design to reach a decision on effectiveness of a drug in treating a disease with the loss of the minimum number of patients. Group sequential designs are very beneficial on this point. However, the proportional hazards assumption must hold to work under a group sequentia...

journal_title：Journal of biopharmaceutical statistics

authors： Demirhan H,Demirhan YP,Bacanli S

更新日期：2013-03-11 00:00:00

abstract：:In literature, there are a few unified approaches to test proof of concept and estimate a target dose, including the multiple comparison procedure using modeling approach, and the permutation approach proposed by Klingenberg. We discuss and compare the operating characteristics of these unified approaches and further ...

journal_title：Journal of biopharmaceutical statistics

authors： Tang Y,Cai C,Sun L,He J

更新日期：2017-01-01 00:00:00

abstract：:Nonparametric methods are presented for the analysis of the two-treatment, two-period crossover design with multivariate response. After forming within-subject sums and differences, the usual tests, including those for carry-over effects and direct treatment effects, can be constructed using a multivariate analysis of...

journal_title：Journal of biopharmaceutical statistics

authors： Johnson WD,Grender JM

更新日期：1993-03-01 00:00:00

abstract：:Receptor occupancy (RO) PET is a non-invasive way to determine drug on target. Given the complexity of procedures, long acquisition times, and high cost, ligand displacement imaging trials often have a limited size and produce sparse RO results over the time course of the blocking drug. To take the best advantage of t...

journal_title：Journal of biopharmaceutical statistics

authors： Vandenhende F,Renard D,Nie Y,Kumar A,Miller J,Tauscher J,Witcher J,Zhou Y,Wong DF

更新日期：2008-01-01 00:00:00

abstract：:In this article, we show how to estimate a transition period for the evolvement of drug resistance to antiretroviral (ARV) drug or other related treatments in the framework of developing a Bayesian method for jointly analyzing time-to-event and longitudinal data. For HIV/AIDS longitudinal data, developmental trajector...

journal_title：Journal of biopharmaceutical statistics

authors： Dagne GA

更新日期：2018-01-01 00:00:00

abstract：:The Wilcoxon-Mann-Whitney (WMW) test is the most commonly used nonparametric method to compare two treatments when the underlying distribution of the outcome variable is not normally distributed. In the presence of stratum effects, the van Elteren (vE) test, a stratified WMW test, can be used to adjust for the stratum...

journal_title：Journal of biopharmaceutical statistics

authors： Qu Y,Zhao YD,Rahardja D

更新日期：2008-01-01 00:00:00

abstract：:During preclinical drug development, the immune system is specifically evaluated after prolonged treatment with drug candidates, because the immune system may be an important target system. The response of antibodies against a T-cell-dependent antigen is recommenced by the FDA and EMEA for the evaluation of immunosupp...

journal_title：Journal of biopharmaceutical statistics

authors： Shkedy Z,Straetemans R,Molenberghs G,Desmidt M,Vinken P,Goeminne N,Coussement W,Van Den Poel B,Bijnens L

更新日期：2005-01-01 00:00:00

abstract：:In recent years, multi-regional clinical trials (MRCT) that conduct clinical trials simultaneously in Asian Pacific region, Europe, and the United States have become very popular for global pharmaceutical development. The main purpose of multi-regional clinical trials is to shorten the time for pharmaceutical developm...

journal_title：Journal of biopharmaceutical statistics

authors： Ying L,Song F,Chow SC,Zeng N,Zheng J,Li X,Henry D,Sethuraman V

更新日期：2018-01-01 00:00:00

abstract：:We assess the QT effect using an exposure-response model in a "thorough QT/QTc study" with a four-period crossover design in which the treatments are placebo, positive control, higher dose of investigational drug, and therapeutic dose of investigational drug. In the study, QTc interval values and the drug concentratio...

journal_title：Journal of biopharmaceutical statistics

authors： Hosmane B,Locke C,Chiu YL

更新日期：2010-05-01 00:00:00

abstract：:The purpose of the research is to develop a statistical decision support algorithm for patients who may benefit from Adjuvant Cisplatin/Vinorelbine (ACT) and improve their survival rates. Genome-wide microarray data are used to identify feasible sets of genes and probe sets that constitute the gene signature. The data...

journal_title：Journal of biopharmaceutical statistics

authors： Moon H,Chao T,Ahn H

更新日期：2020-05-03 00:00:00

abstract：:One of the most critical decision points in clinical development is Go/No-Go decision-making after a proof-of-concept study. Traditional decision-making relies on a formal hypothesis testing with control of type I and type II error rates, which is limited by assessing the strength of efficacy evidence in a small isola...

journal_title：Journal of biopharmaceutical statistics

authors： Huang B,Talukder E,Han L,Kuan PF

更新日期：2019-01-01 00:00:00

abstract：:Failure to recognize the serious implications of heterogeneous correlations and disregard of the multiple test problem in interpreting the results from repeated measurements ANOVA of any single primary outcome measure can produce false-positive error rates that are more than five times the alpha level that is reported...

journal_title：Journal of biopharmaceutical statistics

authors： Overall JE,Doyle SR

更新日期：1996-03-01 00:00:00

abstract：:Using multistage adaptive group sequential test designs, the investigator may perform data-driven changes in the design during the course of the trial without inflation of the Type I error rate. This is possible, for example, through the use of the inverse normal method of combining the p-values from the separate stag...

journal_title：Journal of biopharmaceutical statistics

authors： Wassmer G

更新日期：2003-11-01 00:00:00

abstract：:We propose a new adaptive threshold detection and enrichment design in which the biomarker threshold is adaptively estimated and updated by optimizing a trade-off between the size of the biomarker positive population and the magnitude of the treatment effect in that population. Enrichment is based on an enrollment cri...

journal_title：Journal of biopharmaceutical statistics

authors： Wang T,Wang X,George SL,Zhou H

更新日期：2020-11-11 00:00:00

abstract：:Group sequential methods to allow the possibility of early termination of a trial due to sufficiently convincing results are a standard in therapeutic clinical trials but have been little considered in bioequivalence trials. We investigate the statistical properties of one group sequential approach to bioequivalence t...

journal_title：Journal of biopharmaceutical statistics

authors： Hauck WW,Preston PE,Bois FY

更新日期：1997-03-01 00:00:00

abstract：:The world of medical devices while highly diverse is extremely innovative, and this facilitates the adoption of innovative statistical techniques. Statisticians in the Center for Devices and Radiological Health (CDRH) at the Food and Drug Administration (FDA) have provided leadership in implementing statistical innova...

journal_title：Journal of biopharmaceutical statistics

authors： Campbell G,Yue LQ

更新日期：2016-01-01 00:00:00