Optimal population designs for PK models with serial sampling.

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：: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：: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：: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：: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：:In many clinical trials for chronic conditions a run-in period is used prior to randomization. Often, only those participants who meet certain criteria during the run-in phase go on to get randomized. The others, along with the information that they might have provided, are excluded from the study. This exclusion of t...

journal_title：Journal of biopharmaceutical statistics

authors： Berger VW,Vali B

更新日期：2011-03-01 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

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：:In clinical trials of drug development, patients are often followed for a certain period of time, and the outcome variables are measured at scheduled time intervals. The main interest of the trial is the treatment efficacy at a prespecified time point, which is often the last visit. In such trials, patient dropout is ...

journal_title：Journal of biopharmaceutical statistics

authors： Kong F,Chen YF,Jin K

更新日期：2009-11-01 00:00:00

abstract：:The outcome selection of bioequivalence evaluations for abbreviated new drug applications results in bias towards unity of test-reference ratio estimates, and underestimation of intrasubject variability for the test drug product. In this study, the selection bias in the estimates of testreference ratio and intrasubjec...

journal_title：Journal of biopharmaceutical statistics

authors： Wang Y

更新日期：2000-08-01 00:00:00

abstract：:It has been widely recognized that interim analyses of accumulating data in a clinical trial can inflate type I error. Different methods, from group sequential boundaries to flexible alpha spending functions, have been developed to control the overall type I error at prespecified level. These methods mainly apply to t...

journal_title：Journal of biopharmaceutical statistics

authors： Chen LM,Ibrahim JG,Chu H

更新日期：2014-01-01 00:00:00

abstract：:We develop a Bayesian approach for estimating vaccine efficacy for susceptibility (VEs) and infectiousness (VEI) using outbreak size household data. Our method allows for heterogeneity in transmission probabilities due to factors that are related to individuals' characteristics, such as age, in addition to vaccination...

journal_title：Journal of biopharmaceutical statistics

authors： Davis XM,Waller LA,Haber M

更新日期：2006-01-01 00:00:00

abstract：:A framework is proposed for making quality predictions in situations for which only systematically inaccurate data are available. The predictions are based on the systematically inaccurate data, complete data from similar situations, and expert knowledge. The proposed predictive model is well suited to functional data...

journal_title：Journal of biopharmaceutical statistics

authors： Haaland B,Chiang AY

更新日期：2014-01-01 00:00:00

abstract：:Dunnett's many-to-one test is used frequently today, especially in dose-finding studies. Using Dunnett's test, the Type I error level for the comparison between the raw mean of the control and the raw means of the study drug groups can be exactly calculated for the normal data. However, this computability depends on t...

journal_title：Journal of biopharmaceutical statistics

authors： Shun Z,Silverberg A,Chang CK,Ouyang P

更新日期：2003-02-01 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：: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：: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：:Bowker's test, a generalization of McNemar's test, performs well under the hypothesis of symmetry, but the estimator of variance used in the test is biased when the table is asymmetric and this calls into question the test's performance in non-null situations. We seek an alternative to Bowker's test in search of metho...

journal_title：Journal of biopharmaceutical statistics

authors： May WL,Johnson WD

更新日期：2001-02-01 00:00:00

abstract：:Nonparametric versions of normal theory step-down multiple-test procedures for inferring minimum effective dose (see Tamhane et al. (1)) were developed and studied by Monte Carlo simulation. Two types of step-down testing procedures were examined. For both procedures, pairwise, linear, or Helmert contrasts of mean ran...

journal_title：Journal of biopharmaceutical statistics

authors： Sidik K,Morris RW

更新日期：1999-05-01 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：:Due to the importance of precision medicine, it is essential to identify the right patients for the right treatment. Biomarkers, which have been commonly used in clinical research as well as in clinical practice, can facilitate selection of patients with a good response to the treatment. In this paper, we describe a b...

journal_title：Journal of biopharmaceutical statistics

authors： Diao G,Dong J,Zeng D,Ke C,Rong A,Ibrahim JG

更新日期：2018-01-01 00:00:00

abstract：:Assessment of quality of life (QOL) in clinical trials becomes a challenging task from the viewpoint of clinical biostatistics. The responses of the items for measuring QOL indices usually vary widely from patient to patient and from time to time. Measurement errors might be present in the responses of the items, and ...

journal_title：Journal of biopharmaceutical statistics

authors： Siddiqui O,Ali MW

更新日期：1999-11-01 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：:In traditional dose-finding studies, dose-limiting toxicity (DLT) is determined within a fixed time observation window where DLT is often defined as a binary outcome. In the setting of oncology dose-finding trials, often patients in advanced stage of diseases are enrolled. Therefore, disease progression may occur with...

journal_title：Journal of biopharmaceutical statistics

authors： Biard L,Cheng B,Manji GA,Lee SM

更新日期：2020-09-15 00:00:00

abstract：:For administrative convenience or cost efficiency, we may often employ a cluster randomized trial (CRT), in which randomized units are clusters of patients rather than individual patients. Furthermore, because of ethical reasons or patient's decision, it is not uncommon to encounter data in which there are patients no...

journal_title：Journal of biopharmaceutical statistics

authors： Lui KJ,Chang KC

更新日期：2011-01-01 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：:An important application of confirmatory adaptive designs is the data-driven selection of treatment arms in multi-armed trials. A general methodology for adaptive designs is based on the combination testing principle. Using this principle, selection of treatment arms in multi-armed designs, recalculation of sample siz...

journal_title：Journal of biopharmaceutical statistics

authors： Wassmer G

更新日期：2011-07-01 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 potency of a batch of drug product needs to meet a release limits at the time of release so that the potency at the end of shelf life remains above the lower registration limit (LRL). This article discusses two methods which determine the release limits such that the chance to fail LRL at the end of shelf life of ...

journal_title：Journal of biopharmaceutical statistics

authors： Wei GC

更新日期：1998-03-01 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