A predictive Bayesian approach to the design and analysis of bridging studies.

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 sequential parallel comparison design (SPCD) is a two-stage design recommended for trials with possibly high placebo response. A drug-placebo comparison in the first stage is followed in the second stage by placebo nonresponders being re-randomized between drug and placebo. We describe how SPCD can be used in tria...

journal_title：Journal of biopharmaceutical statistics

authors： Wang JJ,Ivanova A

更新日期：2014-01-01 00:00:00

abstract：:The United States Pharmacopeia (USP) content uniformity sampling acceptance plan consisting of a two-stage sampling plan with criteria on sample mean and number of out-of-range tablets is the standard for compendium. It is, however, often used mistakenly for lot quality assurance. In comparison to the Japan Phamacopei...

journal_title：Journal of biopharmaceutical statistics

authors： Tsong Y,Shen M

更新日期：2007-01-01 00:00:00

abstract：:This paper introduces exact permutation methods for use when there are independent clusters of data with arbitrary within-cluster correlation. To eliminate the problem of clustering, we randomly select a data point from each cluster and for this now independent data, and calculate our test statistic and the associated...

journal_title：Journal of biopharmaceutical statistics

authors： Follmann D,Fay M

更新日期：2010-07-01 00:00:00

abstract：:We studied the sensitivity of the number of unique design points and their placement, in Bayesian optimal designs for pharmacokinetic models, with respect to the magnitude of prior uncertainty. We used two and three-parameter pharmacokinetic models with fixed and mixed effects and two Bayesian optimal design criteria,...

journal_title：Journal of biopharmaceutical statistics

authors： Dokoumetzidis A,Aarons L

更新日期：2007-01-01 00:00:00

abstract：:In this article, a parametric sequential test is proposed under the Weibull model. The proposed test is asymptotically normal with an independent increment structure. The sample size for a fixed sample test is derived for the purpose of group sequential trial design. In addition, a multi-stage group sequential procedu...

journal_title：Journal of biopharmaceutical statistics

authors： Wu J,Xiong X

更新日期：2015-01-01 00:00:00

abstract：:In the early stages of traditional drug development, the frequency of dosing (e.g., QD, BID, etc.) is typically determined by the pharmacokinetic properties of a compound. After an appropriate dose frequency is chosen, the magnitude of dose is then evaluated via parallel-group dose-response trials. For some drugs, how...

journal_title：Journal of biopharmaceutical statistics

authors： Hafner KB,Ruberg SJ

更新日期：1996-07-01 00:00:00

abstract：:The dose-response models for full agonists and for a particular type of partial agonist can be described by sigmoidal curves and bell-shaped curves, respectively. The methods currently used to evaluate the interaction of a full agonist and a partial agonist require a large number of experimental units and base their a...

journal_title：Journal of biopharmaceutical statistics

authors： Ghosh K,Shen ES,Arey BJ,López FJ

更新日期：1998-11-01 00:00:00

abstract：:The problem of testing treatment difference in the occurrence of a study endpoint in a randomized parallel-group comparative clinical trial with repeated responses under the assumption that the responses follow a bivariate zero-inflated Poisson (ZIP) distribution is considered. Likelihood ratio test for homogeneity of...

journal_title：Journal of biopharmaceutical statistics

authors： Yuen HK,Chow SC,Tse SK

更新日期：2015-01-01 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：: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：:Pressures for rapid drug development, especially for treatments that may affect public health significantly, drive a need to reconsider what is necessary to establish the "substantial evidence" of efficacy and safety required for regulatory approval. The concept of substantial evidence of effect can be stated fairly s...

journal_title：Journal of biopharmaceutical statistics

authors： Gould AL

更新日期：2002-02-01 00:00:00

abstract：:Investigating the prevalence of a disease is an important topic in medical studies. Such investigations are usually based on the classification results of a group of subjects according to whether they have the disease. To classify subjects, screening tests that are inexpensive and nonintrusive to the test subjects are...

journal_title：Journal of biopharmaceutical statistics

authors： Tang ML,Qiu SF,Poon WY,Tang NS

更新日期：2012-01-01 00:00:00

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：: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：: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：:Noninferiority multiregional clinical trials (MRCTs) have recently received increasing attention in drug development. While a major goal in an MRCT is to estimate the global treatment effect, it is also important to assess the consistency of treatment effects across multiple regions. In this paper, we propose an intui...

journal_title：Journal of biopharmaceutical statistics

authors： Diao G,Zeng D,Ibrahim JG,Rong A,Lee O,Zhang K,Chen Q

更新日期：2017-01-01 00:00:00

abstract：:In analytical similarity assessment of a biosimilar product, key quality attributes of the test and reference products need to be shown statistically similar. When there were multiple references, similarity among the reference products is also required. We proposed a simultaneous confidence approach based on the fiduc...

journal_title：Journal of biopharmaceutical statistics

authors： Zheng J,Yin D,Yuan M,Chow SC

更新日期：2019-01-01 00:00:00

abstract：:In method comparison and reliability studies, it is often important to assess agreement between multiple measurements made by different methods, devices, laboratories, observers, or instruments. For continuous data, the concordance correlation coefficient (CCC) is a popular index for assessing agreement between multip...

journal_title：Journal of biopharmaceutical statistics

authors： Barnhart HX,Lokhnygina Y,Kosinski AS,Haber M

更新日期：2007-01-01 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：:An integral part of routine health checkups involves laboratory measurements on various analytes in the blood. It is then common to compare the value of two consecutive measurements sampled at different times from the same patient. A "significant" change requires an action (additional sample and/or clinical action). T...

journal_title：Journal of biopharmaceutical statistics

authors： Cohen A,Doveh E,Umansky T

更新日期：2001-01-01 00:00:00

abstract：:A mathematical model is described for selecting combinations of chemotherapeutic drugs in order to maximize antitumor dose intensity subject to constraints on toxicity to normal organ systems. Determination of which drugs to combine and in what proportions to combine them offers combinatorially huge numbers of possibi...

journal_title：Journal of biopharmaceutical statistics

authors： Simon R,Korn EL

更新日期：1991-01-01 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：: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：: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：:We introduce the idea of a design to detect signals of efficacy in early phase clinical trials. Such a design features three possible decisions: to kill the compound; to continue with staged development; or to continue with accelerated development of the compound. We describe how such studies improve the trade-off bet...

journal_title：Journal of biopharmaceutical statistics

authors： Brown MJ,Chuang-Stein C,Kirby S

更新日期：2012-01-01 00:00:00

abstract：:All too often in clinical trials the assessment of quality of life is seen as a bolt-on study. Consequently insufficient consideration is often given to its design, collection, analysis and presentation, and its impact on the trial results and on clinical practice is minimal. In many trials quality of life is a key en...

journal_title：Journal of biopharmaceutical statistics

authors： Stephens R

更新日期：2004-02-01 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：:Sample size calculation formulas for testing equality, noninferiority, superiority, and equivalence based on odds ratio were derived under both parallel and one-arm crossover designs. An example concerning the study of odds ratio between a test compound (treatment) and a standard therapy (control) for prevention of re...

journal_title：Journal of biopharmaceutical statistics

authors： Wang H,Chow SC,Li G

更新日期：2002-11-01 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