Basic regulatory science behind drug substance and drug product specifications of monoclonal antibodies and other protein therapeutics

In this review,we focus on providing basics and examples for each component of the protein therapeutic specifications to interested pharmacists and biopharmaceutical scientists with a goal to strengthen understanding in regulatory science and compliance.Pharmaceutical specifications comprise a list of important quality attributes for testing,references to use for test procedures,and appropriate acceptance criteria for the tests,and they are set up to ensure that when a drug product is administered to a patient,its intended therapeutic benefits and safety can be rendered appropriately.Conformance of drug substance or drug product to the specifications is achieved by testing an article according to the listed tests and analytical methods and obtaining test results that meet the acceptance criteria.Quality attributes are chosen to be tested based on their quality risk,and consideration should be given to the merit of the analytical methods which are associated with the acceptance criteria of the specifications.Acceptance criteria are set forth primarily based on efficacy and safety profiles,with an increasing attention noted for patient-centric specifications.Discussed in this work are related guidelines that support the biopharmaceutical specification setting,how to set the acceptance criteria,and examples of the quality attributes and the analytical methods from 60 articles and 23 pharmacopeial monographs.Outlooks are also explored on process analytical technologies and other orthogonal tools which are on-trend in biopharmaceutical characterization and quality control.

Design of Fully Automatic Specification Selection System for Resistance Welding Equipment

A system for fully automatic selection of welding specifications in resistance welding equipment has been developed to address the problem of workers frequently choosing the wrong specifications during manual welding of multiple parts on a single machine in automobile factories. The system incorporates an automatic recognition system for different workpiece materials using the added machine fixture,visual detection system for nuts and bolts,and secondary graphical confirmation to ensure the correctness of specification calling. This system achieves reliable,fully automatic selection of welding specifications in resistance welding equipment and has shown significant effects in improving welding quality for massproduced workpieces,while solving the problem of specification calling errors that can occur with traditional methods involving process charts and code adjustments. This system is particularly suitable for promoting applications in manual welding of multiple parts on a single machine in automobile factories,ensuring correct specification calling and welding quality.

Product Specification Analysis for Modular Product Design Using Big Sales Data

Big data on product sales are an emerging resource for supporting modular product design to meet diversified customers’requirements of product specification combinations.To better facilitate decision-making of modular product design,correlations among specifications and components originated from customers’conscious and subconscious preferences can be investigated by using big data on product sales.This study proposes a framework and the associated methods for supporting modular product design decisions based on correlation analysis of product specifications and components using big sales data.The correlations of the product specifications are determined by analyzing the collected product sales data.By building the relations between the product components and specifications,a matrix for measuring the correlation among product components is formed for component clustering.Six rules for supporting the decision making of modular product design are proposed based on the frequency analysis of the specification values per component cluster.A case study of electric vehicles illustrates the application of the proposed method.

Coherence cube enhancement based on local histogram specification

Coherence analysis is a powerful tool in seismic interpretation for imaging geological discontinuities such as faults and fractures. However, subtle faults or fractures of one stratum are difficult to be distinguished on coherence sections （time slices or profiles） due to interferences from adjacent strata, especially these with strong reflectivity. In this paper, we propose a coherence enhancement method which applies local histogram specification （LHS） techniques to enhance subtle faults or fractures in the coherence cubes. Unlike the traditional histogram specification （HS） algorithm, our method processes 3D coherence data without discretization. This method partitions a coherence cube into many sub-blocks and self-adaptively specifies the target distribution in each block based on the whole distribution of the coherence cube. Furthermore, the neighboring blocks are partially overlapped to reduce the edge effect. Applications to real datasets show that the new method enhances the details of subtle faults and fractures noticeably.

渐近平均伪轨跟踪性质、弱specification性质和分布混沌

证明了有渐近平均伪轨跟踪性质的非平凡紧致动力系统具有一致分布混沌或者按序列分布混沌。此外,在具有渐近平均伪轨跟踪性质系统中的分布混沌在测度中心是一致和稠密的,即有一个不可数的一致分布混沌集是由这样的点组成,它们的轨道闭包包含测度中心。作为一个推论,具有弱specification性质的系统也有类似的结果。

关于弱Specification性质的一个注记

该文证明具有弱specification性质的系统在其测度中心的限制系统也具有弱specification性质,并且其逆不真.作为推论得到在未有满射的假设下,弱specification性质蕴含渐近平均跟踪性质.最后证明具有弱specification性质的满射系统是一致分布混沌的.

Study on specifications of farmland shelterbelt net in Northeastern Plain of China

s: The farmland shelterbelts in Northeastern Plain of China have formed relatively complete net system. The func-tions of shelterbelt net in omnibearing wind check and prevention of frostbite as well as the field of integrated climate effect within shelterbelt net were analyzed, through located observation of meteorological factors. Within the shelterbelt net, the area with more than 10% efficiency of omnibearing wind check was determined as benefited area. The analysis of yield and quality of crops indicated that the sheltering range of shelterbelt net was 25 times tree height. The mature heights of the various varieties of poplar composed the shelterbelts were determined according to their height growth. Based on the comprehensive analysis above, the suitable size of farmland shelterbelt net in Northeastern Plain of China was decided to be 400 m×400 m.

弱Specification和逆极限空间上移位映射(英文)

对度量空间上连续自映射引进弱Ｓｐｅｃｉｆｉｃａｔｉｏｎ概念，研究了它与浑沌和拓扑熵的联系，此外还讨论了逆极限空间上移位映射的弱Ｓｐｅｃｉｆｉｃａｔｉｏｎ性质。

连续映射的弱specification性质与混沌

specification性质是一种重要的动力性质,对连续的区间映射和树映射,该性质与拓扑混合等价。对紧致度量空间,满足POTP性质的拓扑混合映射具有specification性质。文章对紧致度量空间上连续自映射,研究了弱specification性质与各种混沌之间的关系,证明了具有弱specification性质的系统是Li-Yorke意义下混沌的,是Ruelle-Takens意义下混沌的,是处处混沌的,并且具有性质P。

Remote Control of Unitary Air Conditioner Based on Manufacturing Message Specification

Traditional air conditioner used to be in local control mode. However, with the development of modern information technology, the control of air conditioner will have to support many more functions. As a first step in such a development, we have implemented a remote monitoring system of unitary air conditioners, using the manufacturing message specification (MMS). MMS is an OSI application protocol designed for the remote control and monitoring of real devices. The functions supported are those that an operator would do normally at the console of the unitary air conditioner. Due to the accomplishment of UMCS (Unitary air conditioner MMS Control System), there will be a leap of the application of MMS and the control technology of unitary air conditioner.

Decomposition-Based Visual Function Specification and Auto-Generation of Function

On the software module, this paper proposes a visual specification language(VSL). Based on decomposition, the language imitates men's thinking procedure that decomposes aproblem into smaller ones, then independently solves the results of every small problem to get theresult of original problem (decomposition and synthesis). Besides, the language mixes visual withspecification. With computer supporting, we can implement the software module automatically. It willgreatly improve the quality of software and raise the efficiency of software development. Thesimple definition of VSL, the principle of auto-generation, an example and the future research areintroduced.

Application of jet main region specification model in CFD simulation for room air movement analysis

This paper analyzes the applications of four air terminal device（ATD）models（i.e.,the basic model,the box model,the N-point momentum model,the jet main region specification model）in computational fluid dynamics（CFD）simulation and their performance in case study.A full-scale experiment is performed in an environment chamber,and the measured air velocity and temperature fields are compared with the simulation results by using four ATD models.The velocity and temperature fields are measured by an omni-directional thermo-anemometer system.It demonstrates that the basic model and the box model are not applicable to complicated air terminal devices.At the occupant area,the relative errors between simulated and measured air velocities are less than 20% based on the N-point momentum model and the jet main region specification model.Around the ATD zone,the relative error between the numerical and measured air velocity based on the jet main region specification model is less than 15%.The jet main region specification model is proved to be an applicable approach and a more accurate way to study the airflow pattern around the ATD with complicated geometry.

弱Specification性质与不变概率测度

对紧致度量空间上连续自映射,研究了弱Specification性质与不变概率测度之间的关系,证明了具有弱Specification性质的系统一定存在f:X→X的不变概率测度m,使得Suppm=X,并且f:X→X有满测度中心,即M(f)=X.

弱Specification和伪移位不变集(英文)

研究了弱Specification性质与紧致度量空间上连续映射的伪移位不变集的联系 ,得到的主要结果是 :设f∶X→X是紧致度量空间连续自映射 ,若f具有弱Specification性质 ,则存在正整数M ,使得fM具有伪移位不变集。

一些紧致系统的拓扑序列熵和广义specification性质

研究了紧致度量空间上的连续满射f:X→X和逆极限空间上移位映射σf:Xf→Xf的拓扑序列熵的性质和逆极限空间上移位映射的广义spec ification性质.

Monte Carlo Method for the Uncertainty Evaluation of Spatial Straightness Error Based on New Generation Geometrical Product Specification

Straightness error is an important parameter in measuring high-precision shafts. New generation geometrical product speeifieation（GPS） requires the measurement uncertainty characterizing the reliability of the results should be given together when the measurement result is given. Nowadays most researches on straightness focus on error calculation and only several research projects evaluate the measurement uncertainty based on ＂The Guide to the Expression of Uncertainty in Measurement（GUM）＂. In order to compute spatial straightness error（SSE） accurately and rapidly and overcome the limitations of GUM, a quasi particle swarm optimization（QPSO） is proposed to solve the minimum zone SSE and Monte Carlo Method（MCM） is developed to estimate the measurement uncertainty. The mathematical model of minimum zone SSE is formulated. In QPSO quasi-random sequences are applied to the generation of the initial position and velocity of particles and their velocities are modified by the constriction factor approach. The flow of measurement uncertainty evaluation based on MCM is proposed, where the heart is repeatedly sampling from the probability density function（PDF） for every input quantity and evaluating the model in each case. The minimum zone SSE of a shaft measured on a Coordinate Measuring Machine（CMM） is calculated by QPSO and the measurement uncertainty is evaluated by MCM on the basis of analyzing the uncertainty contributors. The results show that the uncertainty directly influences the product judgment result. Therefore it is scientific and reasonable to consider the influence of the uncertainty in judging whether the parts are accepted or rejected, especially for those located in the uncertainty zone. The proposed method is especially suitable when the PDF of the measurand cannot adequately be approximated by a Gaussian distribution or a scaled and shifted t-distribution and the measurement model is non-linear.

具有specification性质的连续流

研究了具有specification性质连续流的动力性质。主要结论是:(1)具有specmcation性质的连续流是混沌的,且其拓扑熵大于零;(2)specmcation性质在扭扩及逆极限下是不变的。

基于UML Specification实现软件系统测试自动化

本文基于软件系统测试理论及面向对象技术,结合一个合理的可以应用于实践的系统软件自动测试工具模型BUS-SUITE,分析基于UML Spec.实现软件系统测试自动化的理论基础、实现流程及关键技术.

SHADOWING,EXPANSIVENESS AND SPECIFICATION FOR C^1-CONSERVATIVE SYSTEMS

We prove that a Cl-generic volume-preserving dynamical system （diffeomor- phism or flow） has the shadowing property or is expansive or has the weak specification property if and only if it is Anosov. Finally, as in [10, 27], we prove that the Cl-robustness, within the volume-preserving context, of the expansiveness property and the weak specifica- tion property, imply that the dynamical system （diffeomorphism or flow） is Anosov.

Survivability Specification Framework for Dependability-Functionality Codesign of ERTS

In ordet to maintain the dependability of system and meet the functional needof users dtsire, this paper introduces a survivability mechanism into embedded real-time system,and proposes a general comprehensive, approach based on a rigorous definition of survivability. Thisapproach permits a trade-off between the function and the cost of system development. It emphasizesthe ultradependable implementation of crucial function without demanding that of entire system.