GaBI杂志最新特色，2021年第3期

IF 0.3 Q4 PHARMACOLOGY & PHARMACY

GaBI Journal-Generics and Biosimilars Initiative Journal Pub Date : 2021-09-15 DOI:10.5639/gabij.2021.1003.012

P. Walson

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引用次数: 0

摘要

本期《GaBI杂志》包含了一些与评价、描述和使用仿制药和生物类似药相关的非常实际的问题。这些问题包括使用小型，非代表性研究人群，研究地点或产品类型的研究的外推结果相关的不确定性。这些问题在本期三篇文章的评价中表现得很明显。其他文章则说明，在无法获得发表意见所依据的原始数据的情况下，评估发表意见的困难:需要评估实际或潜在利益冲突的可能影响;以及对重要的非医药化学品缺乏一致的监管方法。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

查看原文本刊更多论文

Latest features in GaBI Journal, 2021, Issue 3

This issue of GaBI Journal contains articles dealing with some very practical issues related to the evaluation, describing, and use of generic and biosimilar products. These issues include the uncertainty associated with extrapolating results of studies that used small, non-representative study populations, study sites, or product types. These problems are evident in the evaluation of three articles in this issue. Other articles illustrate difficulties evaluating published opinions without access to the original data upon which such opinions were based: the need to evaluate the possible effects of real or potential conflicts of interest; and the lack of consistent regulatory approaches to important, non-pharmaceutical chemicals.

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来源期刊

GaBI Journal-Generics and Biosimilars Initiative Journal PHARMACOLOGY & PHARMACY-

CiteScore

1.80

自引率

0.00%

发文量

期刊介绍： The scope of GaBI Journal is broad and of interest and relevance to professionals active in clinical practice, pharmaceutical science and policy. Materials published in GaBI Journal include high quality research reports, literature reviews and case studies, all of which are peer reviewed. Manuscripts on all aspects of generic and biosimilar medicines, covering areas in clinical, fundamental, technical, manufacturing, bi-processing, economic and social aspects of pharmaceuticals and therapeutics are welcome. In addition, high quality work submitted in other formats, for example, scientific and evidence-based commentaries, may also be considered. In all cases, the emphasis is on quality, originality and knowledge contribution to those involved in health care. All manuscripts submitted to GaBI Journal are subject to a rigorous peer review process. GaBI Journal plans to be indexed in PubMed within two years, and that indexing will be retrospective. GaBI Journal is published quarterly from 2012. All articles are published in English.