Modeling anti-KLH ELISA data using two-stage and mixed effects models in support of immunotoxicological studies.

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：: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：: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：:Sample size estimation (SSE) is an important issue in the planning of clinical studies. While larger studies are likely to have sufficient power, it may be unethical to expose more patients than necessary to answer a scientific question. Budget considerations may also cause one to limit the study to an adequate size t...

journal_title：Journal of biopharmaceutical statistics

authors： Wu PS,Lin M,Chow SC

更新日期：2016-01-01 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：:In this paper, a propensity score-integrated composite likelihood (PSCL) approach is developed for cases in which the control arm of a two-arm randomized controlled trial (RCT) (treated vs control) is augmented with patients from real-world data (RWD) containing both clinical outcomes and covariates at the patient-lev...

journal_title：Journal of biopharmaceutical statistics

authors： Chen WC,Wang C,Li H,Lu N,Tiwari R,Xu Y,Yue LQ

更新日期：2020-05-03 00:00:00

abstract：:In confidence interval estimation of the difference between two proportions with overdispersion due to positive correlations, the usual asymptotic normality-based method generally has lower coverage rates than desired, especially when sample size is moderate. Applying the concept of effective sample size to existing m...

journal_title：Journal of biopharmaceutical statistics

authors： Chen C,Li J,Zhou Z

更新日期：2004-05-01 00:00:00

abstract：:Statistical methodologies for human abuse potential studies are rarely evaluated. Human abuse potential studies assess whether test drugs produce positive and negative subjective responses on abuse-related measures using volunteers with histories of recreational drug use. These studies typically have a randomized, dou...

journal_title：Journal of biopharmaceutical statistics

authors： Chen L,Bonson KR

更新日期：2013-03-11 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：: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：: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：:We would like to estimate the parameters of a dose-response function with the greatest precision as possible. For a two-parameter model, this is equivalent to minimizing the area of the confidence ellipsoid, i.e., a D-optimal design. Previous work on this particular model has included minimal designs. These designs ar...

journal_title：Journal of biopharmaceutical statistics

authors： Lupinacci PJ,Raghavarao D

更新日期：2000-02-01 00:00:00

abstract：:Historical control trials (HCTs) are frequently conducted to compare an experimental treatment with a control treatment from a previous study, when they are applicable and favored over a randomized clinical trial (RCT) due to feasibility, ethics and cost concerns. Makuch and Simon developed a sample size formula for h...

journal_title：Journal of biopharmaceutical statistics

authors： Zhu H,Zhang S,Ahn C

更新日期：2016-01-01 00:00:00

abstract：:In various pharmaceutical applications, repeated measurements are taken from each subject, and model parameters are estimated from the collected data. Examples include dose response modeling and PK/PD studies with serial blood sampling, among others. The quality of the information in an experiment is reflected in the ...

journal_title：Journal of biopharmaceutical statistics

authors： Gagnon R,Leonov S

更新日期：2005-01-01 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：:The Food and Drug Administration of the United States issued a draft guidance on adaptive design clinical trials in February 2010. This draft guidance has attracted a lot of attention because of the increasing interest in adaptive trials by the pharmaceutical industry in recent years. In this paper, we report on highl...

journal_title：Journal of biopharmaceutical statistics

authors： Chuang-Stein C,Beltangady M

更新日期：2010-11-01 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：:Multiple comparisons are commonly seen in clinical trials and many other fields. An example, which is the focus of this paper, is the comparison of several test treatments (possibly different doses of a compound) with placebo (control). It is well known that steps must be taken to control the type I error rate when mu...

journal_title：Journal of biopharmaceutical statistics

authors： Chen M,Kianifard F

更新日期：1997-07-01 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：:There are minimal standards for the processing of whole blood components, and to apply those standards requires a system of quality assurances. Excessive indications of failures in compliance trigger inspections and other remedial actions, but the demarcation of what is excessive is a critical issue. Issues of low vol...

journal_title：Journal of biopharmaceutical statistics

authors： Lachenbruch PA,Foulkes MA,Williams AE,Epstein JS

更新日期：2005-01-01 00:00:00

abstract：:When performing a pivotal clinical trial, it may be of interest to assess the probability of success (PoS) of that trial. Initially evaluated when the trial is designed, PoS can be updated as the trial progresses and new information about the drug effect becomes available. Such information can be external to the trial...

journal_title：Journal of biopharmaceutical statistics

authors： Rufibach K,Jordan P,Abt M

更新日期：2016-01-01 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：: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：:In 1968 the Food and Drug Administration (FDA) established the Adverse Event Reporting System (AERS) database containing data on adverse events (AEs) reported by patients, health care providers, and other sources through a spontaneous reporting system. FDA uses AERS for monitoring the safety of the drugs on the market...

journal_title：Journal of biopharmaceutical statistics

authors： Huang L,Zalkikar J,Tiwari RC

更新日期：2013-01-01 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：: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：:With the use of finite mixture models for the clustering of a data set, the crucial question of how many clusters there are in the data can be addressed by testing for the smallest number of components in the mixture model compatible with the data. We investigate the performance of a resampling approach to this latter...

journal_title：Journal of biopharmaceutical statistics

authors： McLachlan GJ,Rathnayake SI

更新日期：2011-11-01 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：: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：: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