Non-normal random effects models for immunogenicity assay cut point determination.

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：: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 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：: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：:Clinical trials often use a binary "fold increase" endpoint defined according to the ratio of interval-censored measurement at end-of-study to that at baseline. We propose a simple yet principled analytic approach based on the linear mixed-effects model for interval-censored data for the analysis of such paired measur...

journal_title：Journal of biopharmaceutical statistics

authors： Xu Y,Lam KF,Ooi EE,Wilder-Smith A,Paton NI,Lee LS,Cheung YB

更新日期：2015-01-01 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：: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：:Rubinstein et al. presented a procedure for determining the required duration of accrual for a clinical trial comparing the survival distributions of two treatments using a classical hypothesis testing formulation. Here their testing procedure is modified in two ways. First, the asymptotic variances used in computatio...

journal_title：Journal of biopharmaceutical statistics

authors： Bristol DR

更新日期：1993-09-01 00:00:00

abstract：:To confirm results obtained from local evaluation at investigational centers, many oncology studies utilize blinded independent central review (BICR) to make assessments of the primary endpoint, progression-free survival (PFS). The comparison of data often leads to large discordances between these observations, castin...

journal_title：Journal of biopharmaceutical statistics

authors： Mannino FV,Amit O,Lahiri S

更新日期：2013-01-01 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：: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：: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：: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：: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 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：:A main challenge in molecular diagnostic research is to accurately evaluate the performance of a new nucleic acid amplification test when the reference standard is imperfect. Several approaches, such as discrepant analysis, composite reference standard (CRS) method, or latent class analysis (LCA), are commonly applied...

journal_title：Journal of biopharmaceutical statistics

authors： Tang S,Hemyari P,Canchola JA,Duncan J

更新日期：2018-01-01 00:00:00

abstract：:An attractive application of expression technologies is to predict drug efficacy or safety using expression data of biomarkers. To evaluate the performance of various classification methods for building predictive models, we applied these methods on six expression datasets. These datasets were from studies using micro...

journal_title：Journal of biopharmaceutical statistics

authors： Man MZ,Dyson G,Johnson K,Liao B

更新日期：2004-11-01 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：:Drug-related side effects are one of the leading causes of death and illness in the developed world. Finding genes that modify drug response has the potential to significantly improve drug delivery, by identifying both individuals that can benefit from therapy and those at increased risk of harm. We present a simple a...

journal_title：Journal of biopharmaceutical statistics

authors： He M,Allen A

更新日期：2010-03-01 00:00:00

abstract：:Although asymptotically, the empirical covariance estimator is consistent and robust with respect to the selection of the working correlation matrix, when the sample size is small, its bias may not be negligible. This article proposes a small sample correction for the empirical covariance estimator in general Gaussian...

journal_title：Journal of biopharmaceutical statistics

authors： Fan C,Zhang D,Zhang CH

更新日期：2012-01-01 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：: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：: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：:Patient-reported outcomes are important for assessing the effectiveness of treatments in many disease areas. For this reason, many new instruments that capture patient-reported outcomes have been developed over the past several decades. With the development of each new instrument, there is the ensuing question of what...

journal_title：Journal of biopharmaceutical statistics

authors： Kirby S,Chuang-Stein C,Morris M

更新日期：2010-09-01 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：: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：: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：:A new two-stage design is proposed that is suitable for early detection of the anticancer activity of experimental therapies in Phase II oncology trials. The endpoints of interest are response rate and early progression rate. The anticancer activity is defined by a positive signal in one endpoint and a non-negative si...

journal_title：Journal of biopharmaceutical statistics

authors： Sun LZ,Chen C,Patel K

更新日期：2009-01-01 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：: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