Siu-keung Tse

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This paper concerns techniques for detection of a potential outlier or extreme observation in a bioavailability/bioequivalence study. A bioavailability analysis that includes possible outlying values may affect the decision on bioequivalence. We consider a general crossover model that takes into account period and formulation effects. We derive two test(More)
In recent years, the use of a two-stage seamless design in clinical trials has attracted much attention. A two-stage seamless trial design is referred to as a study design that combines two separate clinical studies that are normally conducted to achieve separate objectives, such as a phase II study for treatment selection and a phase III study for efficacy(More)
This study focuses on strategies and statistical considerations for assessment of translation in language (e.g. translation of case report forms in multinational clinical trials), information (e.g. translation of basic discoveries to the clinic) and technology (e.g. translation of Chinese diagnostic techniques to well-established clinical study endpoints)(More)
This article considers the planning of Type-II interval censored life tests for exponentially distributed lifetimes. In particular, we explore two criteria that are based on the minimization of the asymptotic variance of maximum likelihood estimator of the model parameter and the associated cost of the experiment. A numerical study is conducted to evaluate(More)
In clinical development, an adaptive design combining results from two separate studies (e.g., a seamless adaptive design with a dose finding study phase and a confirmatory study phase) is commonly considered. The purpose of an adaptive design is not only to reduce lead time between the two studies, but also to evaluate the treatment effect in a more(More)
In the pharmaceutical industry, it is desirable to apply an adaptive seamless trial design to combine two separate clinical studies that are normally conducted for achieving separate objectives such as a Phase II study for dose finding and a Phase III confirmatory study for efficacy. As a result, an adaptive seamless Phase II/III trial design consisting of(More)
This paper explores the problem of interval estimation for parameters of Weibull-distributed data, which are Type II progressively censored with random removals. Seven different confidence interval-estimation procedures are considered. Four of them are based on a parametric bootstrapping approach. Others are based on the asymptotic normality method and the(More)
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(More)