Modeling the covariance structure in pharmacokinetic crossover trials.

abstract：:For the assessment of biosimilarity of biosimilar products, the United States (US) Food and Drug Administration (FDA) proposed a stepwise approach for providing the totality-of-the-evidence of similarity between a proposed biosimilar product and a US-licensed (reference) product. The stepwise approach starts with the ...

journal_title：Journal of biopharmaceutical statistics

authors： Wang T,Chow SC

更新日期：2017-01-01 00:00:00

abstract：:An adaptive enrichment design is a randomized trial that allows enrollment criteria to be modified at interim analyses, based on a preset decision rule. When there is prior uncertainty regarding treatment effect heterogeneity, these trial designs can provide improved power for detecting treatment effects in subpopulat...

journal_title：Journal of biopharmaceutical statistics

authors： Fisher A,Rosenblum M,Alzheimer’s Disease Neuroimaging Initiative.

更新日期：2018-01-01 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：:This article discusses the design of a clinical trial where a new treatment will be compared to a control. For a specific type of endpoint, there are a wide variety of test statistics that can be used. Also, the investigator must decide how many patients to accrue in each arm as well as the duration of the study. Afte...

journal_title：Journal of biopharmaceutical statistics

authors： Lawrence J

更新日期：2002-05-01 00:00:00

abstract：:Rank-based test procedures in censored survival data differ considerably in their sensitivity to various alternatives to the hypothesis of equality of underlying distributions. Procedures based on the simultaneous use of multiple statistics provide an appealing approach to obtaining more global sensitivity while maint...

journal_title：Journal of biopharmaceutical statistics

authors： Yang P,Fleming TR

更新日期：2006-01-01 00:00:00

abstract：:To ensure that a drug product will meet standards for identity, strength and stability as specified in the United States Pharmacopedia and National Formulary (USP/NF), it needs to pass a number of tests such as the content uniformity test and dissolution test at various stages of the manufacturing process. The sponsor...

journal_title：Journal of biopharmaceutical statistics

authors： Wang H

更新日期：2007-01-01 00:00:00

abstract：:The ICH E14 guidance (ICH, 2005) recommend that a concurrent positive control should be included in a thorough QTc clinical trial to validate the study. The ICH E14 guidance (ICH, 2005) state that "The positive control should have an effect on the mean QTc interval of about 5 ms (i.e., an effect that is close to the Q...

journal_title：Journal of biopharmaceutical statistics

authors： Zhang J

更新日期：2008-01-01 00:00:00

abstract：:In the era of precision medicine, drugs are increasingly developed to target subgroups of patients with certain biomarkers. In large all-comer trials using a biomarker stratified design, the cost of treating and following patients for clinical outcomes may be prohibitive. With a fixed number of randomized patients, th...

journal_title：Journal of biopharmaceutical statistics

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

更新日期：2018-01-01 00:00:00

abstract：:Fisher's exact test and Pearson's chi-square with continuity correction are frequently employed in the analysis of epidemiological data involving a 2 x 2 contingency table. This paper reviews the concepts and controversies underlying these procedures and discusses their appropriateness and adequacies in analyzing such...

journal_title：Journal of biopharmaceutical statistics

authors： Sahai H,Khurshid A

更新日期：1995-03-01 00:00:00

abstract：:I review the designs available for Phase I dose-finding studies of chemotherapeutic agents in cancer patients. The designs are based on the assumption that both efficacy and toxicity increase with dose, and thus attempt to minimize the number of patients treated at low doses, and also to minimize the chance that patie...

journal_title：Journal of biopharmaceutical statistics

authors： Potter DM

更新日期：2006-01-01 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

abstract：:The small n, Sequential, Multiple Assignment, Randomized Trial (snSMART) is a two-stage clinical trial design for rare diseases motivated by the comparison of three active treatments for isolated skin vasculitis in the ongoing clinical trial ARAMIS (a randomized multicenter study for isolated skin vasculitis, NCT09239...

journal_title：Journal of biopharmaceutical statistics

authors： Wei B,Braun TM,Tamura RN,Kidwell K

更新日期：2020-09-06 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：:Multipopulation tailoring trials provide a trial design option that supports the realization of tailored therapeutics or personalized medicine. Several recent publications have focused on statistical and clinical considerations that arise in these trials that are designed to study the overall treatment effect in a pop...

journal_title：Journal of biopharmaceutical statistics

authors： Millen BA,Dmitrienko A,Song G

更新日期：2014-01-01 00:00:00

abstract：:The design of a three-arm trial including the experimental treatment, an active reference treatment, and a placebo is recommended as a useful approach to the assessment of noninferiority of the experimental treatment. The inclusion of the placebo arm enables the assessment of assay sensitivity and internal validation,...

journal_title：Journal of biopharmaceutical statistics

authors： Hida E,Tango T

更新日期：2013-01-01 00:00:00

abstract：:Testing for noninferiority and equivalence between an experimental therapy and a standard therapy in terms of the ratio of binomial proportions is considered. New tests based on the Fieller-Hinkley distribution of the ratio of random variables are proposed. Restricted maximum likelihood estimates of the null variances...

journal_title：Journal of biopharmaceutical statistics

authors： Koti KM

更新日期：2007-01-01 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：:As more biologic products are going off patent protection, the development of follow-on biologic products (also known as biosimilars) has gained much attention from both the biotechnology industry and regulatory agencies. Unlike small molecules, the development of biologic products is not only more complicated but als...

journal_title：Journal of biopharmaceutical statistics

authors： Zhang N,Yang J,Chow SC,Chi E

更新日期：2014-01-01 00:00:00

abstract：:Clinical trials with data-driven decision rules often pursue multiple clinical objectives such as the evaluation of several endpoints or several doses of an experimental treatment. These complex analysis strategies give rise to "multivariate" multiplicity problems with several components or sources of multiplicity. A ...

journal_title：Journal of biopharmaceutical statistics

authors： Kordzakhia G,Dmitrienko A,Ishida E

更新日期：2018-01-01 00:00:00

abstract：:Bayesian statistical methodology has been used for more than 10 years in medical device premarket submissions to the U.S. Food and Drug Administration (FDA). A complete list of the publicly available information associated with these FDA applications is presented. In addition to the increasing number of Bayesian metho...

journal_title：Journal of biopharmaceutical statistics

authors： Campbell G

更新日期：2011-09-01 00:00:00

abstract：:We provide a set of formulas that allow the combination of separately performed analyses of population pharmacokinetic (PK) studies, without any further computational effort. More specifically, given the point estimates and uncertainties of two population PK analyses, the formulas provide the point estimates and uncer...

journal_title：Journal of biopharmaceutical statistics

authors： Dokoumetzidis A,Aarons L

更新日期：2008-01-01 00:00:00

abstract：:The van Elteren test, as a type of stratified Wilcoxon-Mann-Whitney test for comparing two treatments accounting for stratum effects, has been used to replace the analysis of variance when the normality assumption was seriously violated. The sample size estimation methods for the van Elteren test have been proposed an...

journal_title：Journal of biopharmaceutical statistics

authors： Zhao YD,Qu Y,Rahardja D

更新日期：2006-01-01 00:00:00

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：:During a clinical trial, balancing statistical and ethical considerations are important. Response-adaptive randomization methods use the information from past patients to increase the probability of the next patient receiving the better treatment while avoiding the statistical concern of selection bias. We compared th...

journal_title：Journal of biopharmaceutical statistics

authors： Piccorelli AV,Fraker SA

更新日期：2018-01-01 00:00:00

abstract：:The widely used distinction of Little and Rubin (1) about types of randomness for missing data presents difficulties in its application to dropouts in longitudinal repeated measurement studies. In its place, a new typology of randomness for dropouts is proposed that relies on using a survival model for the dropout pro...

journal_title：Journal of biopharmaceutical statistics

authors： Lindsey JK

更新日期：2000-11-01 00:00:00

abstract：:In cancer drug development, demonstrated efficacy in tumor xenograft models is an important step toward bringing a promising compound to human use. A key outcome variable is tumor volume measured over a period of time, while mice are treated with certain treatment regimens. A constrained parametric model has been prop...

journal_title：Journal of biopharmaceutical statistics

authors： Fang HB,Deng D,Zhang T,Tan M

更新日期：2014-01-01 00:00:00

abstract：:Predictive probability is particularly useful in aiding a decision-making process related to drug development. This is especially true for decisions occurring as the result of interim analyses of clinical trials. Examples of clinical trial applications of Bayesian predictive probability and the use of the beta-binomia...

journal_title：Journal of biopharmaceutical statistics

authors： Johns D,Andersen JS

更新日期：1999-03-01 00:00:00

abstract：:Analyses of multicenter trials consider the estimated treatment effect differences of the individual centers and combine them into an estimate of the overall treatment effect. There has been much debate in the literature concerning the best way to combine these treatment effect differences. We emphasize that first of ...

journal_title：Journal of biopharmaceutical statistics

authors： Dragalin V,Fedorov V,Jones B,Rockhold F

更新日期：2001-11-01 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：:For noninferiority testing with the maximum allowable noninferiority margin being prespecified, one can perform valid statistical testing at the same alpha level for multiple noninferiority hypotheses with margins being smaller than this maximum margin. This is easily comprehensible because only one confidence level i...

journal_title：Journal of biopharmaceutical statistics

authors： Hung HM,Wang SJ

更新日期：2004-05-01 00:00:00