GaBI杂志最新特色,2021年第3期

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。
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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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