Methodology for the validation of analytical methods involved in uniformity of dosage units tests

Validation of analytical methods is required prior to their routine use. In addition, the current implementation of the Quality by Design (QbD) framework in the pharmaceutical industries aims at improving the quality of the end products starting from its early design stage. However, no regulatory guideline or none of the published methodologies to assess method validation propose decision methodologies that effectively take into account the final purpose of developed analytical methods. In this work a solution is proposed for the specific case of validating analytical methods involved in the assessment of the content uniformity or uniformity of dosage units of a batch of pharmaceutical drug products as proposed in the European or US pharmacopoeias. This methodology uses statistical tolerance intervals as decision tools. Moreover it adequately defines the Analytical Target Profile of analytical methods in order to obtain analytical methods that allow to make correct decisions about Content uniformity or uniformity of dosage units with high probability. The applicability of the proposed methodology is further illustrated using an HPLC-UV assay as well as a near infra-red spectrophotometric method.     

The revised Australian fiberscopic profile

The Australian Fiberscopic Profile (AFP) was developed for use in a previous study of normal voices to provide standard documentation for examining the larynx under continuous light. The AFP is being used currently in five specialized voice clinics in Australia to collect data on dysphonic voices. After use with 40 clients it became obvious that a revision with clearer definitions of the parameters was needed to make it a more useful clinical tool.     

利用反应离子刻蚀实现GaAs晶片通孔工艺

贯穿晶片的背面通孔已成为ＧａＡｓＭＭＩＣ和功率ＭＥＳＦＥＴ的有效接地方式。本文介绍了利用Ｃｌ２／ＳｉＣｌ４作为反应气体，以正性光刻胶为掩模的反应离子刻蚀背孔工艺。利用该工艺刻蚀出的深孔具有倾斜的剖面和光滑的侧壁，孔的横向侧蚀小，在５０ｍｍＧａＡｓ圆片上获得了良好的均匀性和重复性。     

Dynamics of mixed protein–surfactant layers adsorbed at the water/air and water/oil interface

Drop and bubble shape tensiometry experiments are performed at the water/air and water/hexane interfaces in order to get more information about the differences in the adsorption layer structure of mixed protein/surfactant systems. For mixtures of β-lactoglobulin and sodium dodecyl sulphate the adsorption at the water/air interface is essentially a competitive process between protein/surfactant complexes and free surfactant molecules, while the water/oil interface is essentially covered by the complexes.     

Profile硬盘广告自动播出系统的应用

本阐述了我台开发使用硬盘广告自动播出系统的情况，及在长期的使用中发现问题，解决问题，使系统建设更加完善，以保证广告播出优质、安全。为我台在2003年度建立新闻资讯中心和全数字化硬盘播出系统奠定了坚实的技术基础。     

An Upper Bound on the Average Size of Silhouettes

It is a widely observed phenomenon in computer graphics that the size of the silhouette of a polyhedron is much smaller than the size of the whole polyhedron. This paper provides, for the first time, theoretical evidence supporting this for a large class of objects, namely for polyhedra or, more generally, tessellated surfaces that approximate surfaces in some reasonable way. The approximated surfaces are two-manifolds that may be nonconvex and nondifferentiable and may have boundaries. The tessellated surfaces should, roughly speaking, have no short edges, have fat faces, and the distance between the mesh and the surface it approximates should never be too large. We prove that such tessellated surfaces of complexity n have silhouettes of expected size where the average is taken over all points of view. The viewpoints can be chosen at random at infinity or at random in a bounded region.     

变系数单指标模型的B-样条估计

变系数单指标模型结合和单指标和变系数模型的优点,在许多领域中有着重要的应用。本文我们基于B-样条逼近,提出了两种估计方法：第一种方法是利用Newton-Raphson迭代方法同时获得参数和非参数部分的估计;第二个方法是剖面方法获得了相应的估计。当模型中有许多参数时,我们建议使用第二种估计方法,而当参数个数较少时采用第一种方法更方便。两个模拟例子用来验证本文提出的估计方法。     

Semi- and Nonparametric Modeling of Ordinal Data

Parametric models for categorical ordinal response variables, like the proportional odds model or the continuation ratio model, assume that the predictor is given by a linear form of covariates. In this article the parametric models are extended to include smooth components in a semiparametric or partially parametric fashion. Parts of the covariates are thereby modeled linearly while other covariates are modeled as unspecified but smooth functions. Estimation is based on a combination of local likelihood and profile likelihood and asymptotic properties of the estimates are derived. In a simulation study it is demonstrated that the profile likelihood approach is to be preferred over a backfitting procedure. Two data examples demonstrate the applicability of the models.     

Circles in torus-torus intersections

We present a procedure to compute all the circles in the intersection curve of two tori, based on the geometric properties of the circles embedded in a torus. By using the geometric constraints in computing the circles, our algorithm provides an efficient and robust solution.