• Title/Summary/Keyword: Generic copies

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A Bayesian Meta Analysis for Assessing Bioequivalence among Two Generic Copies of the Same Brand-Name Drug

  • Oh, Hyun-Sook
    • Communications for Statistical Applications and Methods
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    • v.13 no.2
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    • pp.285-295
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    • 2006
  • As more generic drugs become available, the quality, safety, and efficacy of generic drugs have become a public concern. Specifically, drug interchangeability among generic copies of the same brand-name drug is a safety concern. This research proposes a Bayesian method for assessing bioequivalence between two generic copies of the same brand-name drug from two independent $2{\times}2$ crossover design experiments. Uninformative priors are considered for general use and the posterior distribution of the difference of two generic drug effects is derived from which the highest probability density interval can be evaluated. Examples are presented for illustration.

Issues of Workplace in Korea: How to Inspire Temporary Workers?

  • Yang, Hoe-Chang;Khan, Tasnuva
    • Asian Journal of Business Environment
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    • v.3 no.1
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    • pp.23-27
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    • 2013
  • Purpose - This study will focus on motivation of temporary workers working in distributors as well as generic companies, especially MPS (motivating potential score) proposed by job characteristics model. We think that temporary workers required intrinsic motivation in order to commit with their organization because they are difficult switch-regular workers due to glass ceiling. Research design, data, methodology - This study operates a survey targeting temporary workers, specifically, we used 144 copies except uncollected copies and dishonesty response of total 165 copies on analysis. We used multiple regression and 3 step regression to investigate the proposed model. Results - The high level of perceived distributional justice and procedural justice was increased the level of organizational commitment, respectively. And, MPS was increased the level of organizational commitment, too. Finally, this study showed that both justice and Job characteristics were very important to increase organizational commitment. Conclusions - In order to inspire temporary workers, the company provides placing enough considering job characteristics as well as fairness of the procedure and distribution. Also, to more fully understand the underlying processes between HRM (Human Resource Management) concepts, new fundamental methods may be required such as switch full-time opportunities.

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Statistical Considerations in the Design of Biosimilar Cancer Clinical Trials

  • Ahn, Chul;Lee, Seung-Chun
    • The Korean Journal of Applied Statistics
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    • v.24 no.3
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    • pp.495-503
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    • 2011
  • When a patent of an innovative (brand-name) small-molecule drug expires, generic copies of the innovative drug may be marketed if their therapeutic equivalence to the innovative drug has been shown. The small-molecule drugs are considered therapeutically equivalent and can be used interchangeably if two drugs are shown to be pharmaceutically equivalent with identical active substance and bioequivalent with comparable pharmacokinetics in a crossover clinical trial. However, the therapeutic equivalence paradigm cannot be applied to biosimilars since the active ingredients of biosimilars are huge molecules with complex and heterogeneous structures, and these molecules are difficult to replicate in every detail. The European Medicine Agency(EMEA) has introduced a regulatory biosimilar pathway which mandates clinical trials to show therapeutic equivalence. In this paper, we discuss statistical considerations in the design and analysis of biosimilar cancer clinical trials.

A framework for parallel processing in multiblock flow computations (다중블록 유동해석에서 병렬처리를 위한 시스템의 구조)

  • Park, Sang-Geun;Lee, Geon-U
    • Transactions of the Korean Society of Mechanical Engineers B
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    • v.21 no.8
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    • pp.1024-1033
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    • 1997
  • The past several years have witnessed an ever-increasing acceptance and adoption of parallel processing, both for high performance scientific computing as well as for more general purpose applications. Furthermore with increasing needs to perform the complex flow calculations in an efficient manner, the use of the message passing model on distributed networks has emerged as an important alternative to the expensive supercomputers. This work attempts to provide a generic framework to enable the parallelization of all CFD-related works using the master-slave model. This framework consists of (1) input geometry, (2) domain decomposition, (3) grid generation, (4) flow computations, (5) flow visualization, and (6) output display as the sequential components, but performs computations for (2) to (5) in parallel on the workstation clustering. The flow computations are parallized by having multiple copies of the flow-code to solve a PDE on different spatial regions on different processors, while their flow data are exchanged across the region boundaries, and the solution is time-stepped. The Parallel Virtual Machine (PVM) is used for distributed communication in this work.

The Operation of Domestic Women's Apparel Fashion Designer - Focusing on Brand type and Fashion Merchandising Process -

  • Lee, Eun-A;Kwon, Hae-Sook
    • Journal of Fashion Business
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    • v.10 no.3
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    • pp.87-99
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    • 2006
  • For comprehending the duties of fashion designer, Sharon(1989) has suggested to look at the procedure how the goods are being produced. The purpose of this research is to identify the task of domestic fashion designer by comparing and analyzing one's work range and performing level in the fashion merchandising process according to the brand types which one is involved in. The preliminary research for the questionnaire was conducted with 5 chief designers of woman's apparel manufactures in Seoul. They were asked to judge if designer's tasks fit to their carry-out operations in the pre-fixed questionnaire which had been done based on preliminary researches and literatures related with fashion merchandising process. The contents of research questionnaire are 11 questions to understand the general characteristics of companies and the participated subjects, and 42 questions to understand the designers' operations. For the selection of NB, among 503 domestic female apparel brands that were in 'Korean Textile Fashion yearbook (2002-2003), the companies that were located in Seoul and possible for cooperation by researcher's personal relationship were selected. For DB, cooperation was requested for brands that were located in Seoul among the 137 brands that participates on Domestic Collection. For GB, 50 stores were selected at random or by personal relationship among 32 GB shops such as Freya Town, Doosan Tower, New Zone, and so on. Total 300 questionnaire distributed to the designers, 192 copies were used for final data analysis. For data analysis, descriptive statistics and ANOVA, Sceffe test were used using SPSS V. 11 1. The participated fashion designers operated 41 categories of suggested 42 categories in the fashion merchandising process. 2. The ranges and contents of tasks in the fashion merchandising process that fashion designers mainly carry-out are very different according to the brand types and showed much different level of task carry-out. Only in the categories of 'fashion trend information' and 'design ideation', all three brand type showed the highest level of task performance. And the design related tasks presented common higher level of performance than the other tasks in all brand types. In order to comprehend the operation of fashion designer, various approaching methods are required according to various apparel manufactures' characteristics.