On the estimation of total variability in assay validation.

Abstract:

:In the pharmaceutical industry, an assay method is considered validated if the accuracy and precision for an assay meet some acceptable limits. This paper discusses the assessment of assay precision in terms of the estimation of total variability of an assay from a one-way random effects model which is often considered in assay validation. We propose a general class of estimators that includes the analysis of variance estimator and the maximum likelihood estimator. We derive the optimal estimator, in terms of smallest mean squared error, within this class and consider an approximate version of this optimal estimator. We report on a Monte Carlo simulation to study its finite sample performance. We also present two examples to illustrate the use of the proposed methodology.

journal_name

Stat Med

journal_title

Statistics in medicine

authors

Chow SC,Tse SK

doi

10.1002/sim.4780101006

subject

Has Abstract

pub_date

1991-10-01 00:00:00

pages

1543-53

issue

10

eissn

0277-6715

issn

1097-0258

journal_volume

10

pub_type

杂志文章
  • Assessing local influence in principal component analysis with application to haematology study data.

    abstract::In many medical and health studies, high-dimensional data are often encountered. Principal component analysis (PCA) is a commonly used technique to reduce such data to a few components that includes most of the information provided by the original data. However, PCA is known to be very sensitive to some abnormal obser...

    journal_title:Statistics in medicine

    pub_type: 杂志文章

    doi:10.1002/sim.2747

    authors: Fung WK,Gu H,Xiang L,Yau KK

    更新日期:2007-06-15 00:00:00

  • Semiparametric transformation models for joint analysis of multivariate recurrent and terminal events.

    abstract::Recurrent event data occur in many clinical and observational studies, and in these situations, there may exist a terminal event such as death that is related to the recurrent event of interest. In addition, sometimes more than one type of recurrent events may occur, that is, one may encounter multivariate recurrent e...

    journal_title:Statistics in medicine

    pub_type: 杂志文章

    doi:10.1002/sim.4306

    authors: Zhu L,Sun J,Srivastava DK,Tong X,Leisenring W,Zhang H,Robison LL

    更新日期:2011-11-10 00:00:00

  • Correction of sampling bias in a cross-sectional study of post-surgical complications.

    abstract::Cross-sectional designs are often used to monitor the proportion of infections and other post-surgical complications acquired in hospitals. However, conventional methods for estimating incidence proportions when applied to cross-sectional data may provide estimators that are highly biased, as cross-sectional designs t...

    journal_title:Statistics in medicine

    pub_type: 杂志文章

    doi:10.1002/sim.5608

    authors: Fluss R,Mandel M,Freedman LS,Weiss IS,Zohar AE,Haklai Z,Gordon ES,Simchen E

    更新日期:2013-06-30 00:00:00

  • An analysis of eight 95 per cent confidence intervals for a ratio of Poisson parameters when events are rare.

    abstract::We compared eight nominal 95 per cent confidence intervals for the ratio of two Poisson parameters, both assumed small, on their true coverage (the probability that the interval includes the ratio of Poisson parameters) and median width. The commonly used log-linear interval, justified by asymptotic considerations, pr...

    journal_title:Statistics in medicine

    pub_type: 杂志文章

    doi:10.1002/sim.3234

    authors: Barker L,Cadwell BL

    更新日期:2008-09-10 00:00:00

  • A prediction-based test for multiple endpoints.

    abstract::This article introduces a global hypothesis test intended for studies with multiple endpoints. Our test makes use of a priori predictions about the direction of the result of each endpoint and we weight these predictions using the sample correlation matrix. The global alternative hypothesis concerns a parameter, ...

    journal_title:Statistics in medicine

    pub_type: 杂志文章

    doi:10.1002/sim.8724

    authors: Montgomery RN,Mahnken JD

    更新日期:2020-12-10 00:00:00

  • Beta-binomial/Poisson regression models for repeated bivariate counts.

    abstract::We analyze data obtained from a study designed to evaluate training effects on the performance of certain motor activities of Parkinson's disease patients. Maximum likelihood methods were used to fit beta-binomial/Poisson regression models tailored to evaluate the effects of training on the numbers of attempted and su...

    journal_title:Statistics in medicine

    pub_type: 杂志文章

    doi:10.1002/sim.3303

    authors: Lora MI,Singer JM

    更新日期:2008-07-30 00:00:00

  • Weighted hurdle regression method for joint modeling of cardiovascular events likelihood and rate in the US dialysis population.

    abstract::We propose a new weighted hurdle regression method for modeling count data, with particular interest in modeling cardiovascular events in patients on dialysis. Cardiovascular disease remains one of the leading causes of hospitalization and death in this population. Our aim is to jointly model the relationship/associat...

    journal_title:Statistics in medicine

    pub_type: 杂志文章

    doi:10.1002/sim.6232

    authors: Sentürk D,Dalrymple LS,Mu Y,Nguyen DV

    更新日期:2014-11-10 00:00:00

  • A joint test for progression and survival with interval-censored data from a cancer clinical trial.

    abstract::Clinical trials often assess efficacy by comparing treatments on the basis of two or more event-time outcomes. In the case of cancer clinical trials, progression-free survival (PFS), which is the minimum of the time from randomization to progression or to death, summarizes the comparison of treatments on the hazards f...

    journal_title:Statistics in medicine

    pub_type: 杂志文章

    doi:10.1002/sim.6096

    authors: Finkelstein DM,Schoenfeld DA

    更新日期:2014-05-30 00:00:00

  • Survival analysis for recurrent event data: an application to childhood infectious diseases.

    abstract::Many extensions of survival models based on the Cox proportional hazards approach have been proposed to handle clustered or multiple event data. Of particular note are five Cox-based models for recurrent event data: Andersen and Gill (AG); Wei, Lin and Weissfeld (WLW); Prentice, Williams and Peterson, total time (PWP-...

    journal_title:Statistics in medicine

    pub_type: 临床试验,杂志文章,随机对照试验

    doi:10.1002/(sici)1097-0258(20000115)19:1<13::aid-sim2

    authors: Kelly PJ,Lim LL

    更新日期:2000-01-15 00:00:00

  • A refined method for the meta-analysis of controlled clinical trials with binary outcome.

    abstract::For the meta-analysis of controlled clinical trials with binary outcome a test statistic for testing an overall treatment effect is proposed, which is based on a refined estimator for the variance of the treatment effect estimator usually used in the random-effects model of meta-analysis. In simulation studies it is s...

    journal_title:Statistics in medicine

    pub_type: 杂志文章

    doi:10.1002/sim.1009

    authors: Hartung J,Knapp G

    更新日期:2001-12-30 00:00:00

  • Heterogeneity in the probability of HIV transmission per sexual contact: the case of male-to-female transmission in penile-vaginal intercourse.

    abstract::Recent studies have indicated variation in the infectivity beta of HIV among heterosexual couples. We represent this heterogeneity by modelling beta as a random variable. Using data on the number of contacts and seroconversion of couples, we fit the model by maximum-likelihood estimation with a beta distribution and a...

    journal_title:Statistics in medicine

    pub_type: 杂志文章

    doi:10.1002/sim.4780080110

    authors: Wiley JA,Herschkorn SJ,Padian NS

    更新日期:1989-01-01 00:00:00

  • A practical approach for the assessment of bioequivalence under selected higher-order cross-over designs.

    abstract::The two-period cross-over design with two sequences of drug administration is a standard experimental design when bioequivalence of one test formulation is to be assessed in comparison with a reference formulation. Previously, an approach based on Fieller's confidence interval has been presented for the assessment of ...

    journal_title:Statistics in medicine

    pub_type: 杂志文章

    doi:10.1002/(sici)1097-0258(19971015)16:19<2229::aid-s

    authors: Vuorinen J

    更新日期:1997-10-15 00:00:00

  • A general frailty model to accommodate individual heterogeneity in the acquisition of multiple infections: An application to bivariate current status data.

    abstract::The analysis of multivariate time-to-event (TTE) data can become complicated due to the presence of clustering, leading to dependence between multiple event times. For a long time, (conditional) frailty models and (marginal) copula models have been used to analyze clustered TTE data. In this article, we propose a gene...

    journal_title:Statistics in medicine

    pub_type: 杂志文章

    doi:10.1002/sim.8506

    authors: Tran TMP,Abrams S,Braekers R

    更新日期:2020-05-30 00:00:00

  • Inference for multimarker adaptive enrichment trials.

    abstract::Identification of treatment selection biomarkers has become very important in cancer drug development. Adaptive enrichment designs have been developed for situations where a unique treatment selection biomarker is not apparent based on the mechanism of action of the drug. With such designs, the eligibility rules may b...

    journal_title:Statistics in medicine

    pub_type: 杂志文章

    doi:10.1002/sim.7422

    authors: Simon R,Simon N

    更新日期:2017-11-20 00:00:00

  • An application of kappa-type analyses to interobserver variation in classifying chest radiographs for pneumoconiosis.

    abstract::We investigated interobserver variation between three physician readers in the independent classification of chest radiographs from 1771 taconite workers for pneumoconiosis. We analysed variation with a general methodology for the analysis of categorical data, and quantified interobserver agreement in terms of kappa-t...

    journal_title:Statistics in medicine

    pub_type: 杂志文章

    doi:10.1002/sim.4780030109

    authors: Musch DC,Landis JR,Higgins IT,Gilson JC,Jones RN

    更新日期:1984-01-01 00:00:00

  • Analysis of additive risk model with high-dimensional covariates using partial least squares.

    abstract::In this paper, we construct a partial additive regression (PAR) model to predict the survival times of cancer patients based on microarray gene expression data with right censoring. The area under time-dependent receiver operating characteristic curve is used as a model evaluation criterion. We conduct a simulation st...

    journal_title:Statistics in medicine

    pub_type: 杂志文章

    doi:10.1002/sim.3412

    authors: Zhao Y,Zhou Y,Zhao M

    更新日期:2009-01-30 00:00:00

  • Parametric multistate survival models: Flexible modelling allowing transition-specific distributions with application to estimating clinically useful measures of effect differences.

    abstract::Multistate models are increasingly being used to model complex disease profiles. By modelling transitions between disease states, accounting for competing events at each transition, we can gain a much richer understanding of patient trajectories and how risk factors impact over the entire disease pathway. In this arti...

    journal_title:Statistics in medicine

    pub_type: 杂志文章

    doi:10.1002/sim.7448

    authors: Crowther MJ,Lambert PC

    更新日期:2017-12-20 00:00:00

  • Variable selection for proportional odds model.

    abstract::In this paper we study the problem of variable selection for the proportional odds model, which is a useful alternative to the proportional hazards model and might be appropriate when the proportional hazards assumption is not satisfied. We propose to fit the proportional odds model by maximizing the marginal likeliho...

    journal_title:Statistics in medicine

    pub_type: 杂志文章

    doi:10.1002/sim.2833

    authors: Lu W,Zhang HH

    更新日期:2007-09-10 00:00:00

  • Group sequential designs for clinical trials with bivariate endpoints.

    abstract::Although all clinical trials are designed and monitored using more than one endpoint, methods are needed to assure that decision criteria are chosen to reflect the clinically relevant tradeoffs that assure the trial's scientific integrity. This article presents a framework for the design and monitoring clinical trials...

    journal_title:Statistics in medicine

    pub_type: 杂志文章

    doi:10.1002/sim.8696

    authors: Hu J,Blatchford PJ,Goldenberg NA,Kittelson JM

    更新日期:2020-11-20 00:00:00

  • Marker values at the time of an AIDS diagnosis.

    abstract::In this paper statistical methods are proposed to estimate the distribution of a CD4 T-cell number at the time of a clinical AIDS endpoint from serial measurements of CD4 T-cell values in a cohort study. The statistical formulation of the problem is that of survival analysis with interval censored data, but in which t...

    journal_title:Statistics in medicine

    pub_type: 杂志文章

    doi:10.1002/sim.4780131915

    authors: Taylor JM,Kim DK

    更新日期:1994-10-15 00:00:00

  • Estimating age-related trends in cross-sectional studies using S-distributions.

    abstract::Growth trends in children are often based on cross-sectional studies, in which a sample of the population is investigated at one given point in time. Estimating age-related percentiles in such studies involves fitting data distributions, each of which is specific for one age group, and a subsequent smoothing of the pe...

    journal_title:Statistics in medicine

    pub_type: 杂志文章

    doi:10.1002/(sici)1097-0258(20000315)19:5<697::aid-sim

    authors: Sorribas A,March J,Voit EO

    更新日期:2000-03-15 00:00:00

  • A transition model for quality-of-life data with non-ignorable non-monotone missing data.

    abstract::In this paper, we consider a full likelihood method to analyze continuous longitudinal responses with non-ignorable non-monotone missing data. We consider a transition probability model for the missingness mechanism. A first-order Markov dependence structure is assumed for both the missingness mechanism and observed d...

    journal_title:Statistics in medicine

    pub_type: 杂志文章

    doi:10.1002/sim.5359

    authors: Liao K,Freres DR,Troxel AB

    更新日期:2012-12-10 00:00:00

  • Assessing the effect of interventions in the context of mixture distributions with detection limits.

    abstract::Many quantitative assay measurements of metabolites of environmental toxicants in clinical investigations are subject to left censoring due to values falling below assay detection limits. Moreover, when observations occur in both unexposed individuals and exposed individuals who reflect a mixture of two distributions ...

    journal_title:Statistics in medicine

    pub_type: 临床试验,杂志文章,随机对照试验

    doi:10.1002/sim.2079

    authors: Chu H,Kensler TW,Muñoz A

    更新日期:2005-07-15 00:00:00

  • Group sequential designs for cure rate models with early stopping in favour of the null hypothesis.

    abstract::Ewell and Ibrahim derived the large sample distribution of the logrank statistic under general local alternatives. Their asymptotic results enable us to extend several group sequential designs which allow for early stopping in favour of the null hypothesis to the setting in which the cure rate model is appropriate. In...

    journal_title:Statistics in medicine

    pub_type: 杂志文章

    doi:10.1002/1097-0258(20001130)19:22<3023::aid-sim638>

    authors: Patricia Bernardo MV,Ibrahim JG

    更新日期:2000-11-30 00:00:00

  • Discovering early diabetic neuropathy from epidermal nerve fiber patterns.

    abstract::Epidermal nerve fibre (ENF) density and morphology are used to study small fibre involvement in diabetic, HIV, chemotherapy induced and other neuropathies. ENF density and summed length of ENFs per epidermal surface area are reduced, and ENFs may appear more clustered within the epidermis in subjects with small fibre ...

    journal_title:Statistics in medicine

    pub_type: 杂志文章

    doi:10.1002/sim.7009

    authors: Andersson C,Guttorp P,Särkkä A

    更新日期:2016-10-30 00:00:00

  • Methods for analyzing data from probabilistic linkage strategies based on partially identifying variables.

    abstract::In record linkage studies, unique identifiers are often not available, and therefore, the linkage procedure depends on combinations of partially identifying variables with low discriminating power. As a consequence, wrongly linked covariate and outcome pairs will be created and bias further analysis of the linked data...

    journal_title:Statistics in medicine

    pub_type: 杂志文章

    doi:10.1002/sim.5498

    authors: Hof MH,Zwinderman AH

    更新日期:2012-12-30 00:00:00

  • Testing goodness-of-fit of the logistic regression model in case-control studies using sample reweighting.

    abstract::A new goodness-of-fit test for the logistic regression model is proposed. It exploits the property of this model that when it is correct, i.e. not misspecified, the parameter estimates are (asymptotically) invariant under reweighting the observations by weights wi that are a function of the binary (0/1) outcomes yi. M...

    journal_title:Statistics in medicine

    pub_type: 杂志文章

    doi:10.1002/sim.1997

    authors: Nagelkerke N,Smits J,le Cessie S,van Houwelingen H

    更新日期:2005-01-15 00:00:00

  • Maximum likelihood estimation of the kappa coefficient from models of matched binary responses.

    abstract::We present an estimate of the kappa-coefficient of agreement between two methods of rating based on matched pairs of binary responses and show that the estimate depends on the common intraclass correlation coefficient between the pairs. Via Monte Carlo simulation, we investigate power of the test of significance on ka...

    journal_title:Statistics in medicine

    pub_type: 杂志文章

    doi:10.1002/sim.4780140109

    authors: Shoukri MM,Martin SW,Mian IU

    更新日期:1995-01-15 00:00:00

  • Assessing neural activity related to decision-making through flexible odds ratio curves and their derivatives.

    abstract::It is well established that neural activity is stochastically modulated over time. Therefore, direct comparisons across experimental conditions and determination of change points or maximum firing rates are not straightforward. This study sought to compare temporal firing probability curves that may vary across groups...

    journal_title:Statistics in medicine

    pub_type: 杂志文章

    doi:10.1002/sim.4220

    authors: Roca-Pardiñas J,Cadarso-Suárez C,Pardo-Vazquez JL,Leboran V,Molenberghs G,Faes C,Acuña C

    更新日期:2011-06-30 00:00:00

  • Smooth bootstrap methods for analysis of longitudinal data.

    abstract::In analysis of longitudinal data, the variance matrix of the parameter estimates is usually estimated by the 'sandwich' method, in which the variance for each subject is estimated by its residual products. We propose smooth bootstrap methods by perturbing the estimating functions to obtain 'bootstrapped' realizations ...

    journal_title:Statistics in medicine

    pub_type: 杂志文章

    doi:10.1002/sim.3027

    authors: Li Y,Wang YG

    更新日期:2008-03-30 00:00:00