癌症生物类似药的IV期临床试验:试验“篮子概念”的外推

Journal of Pharmacy Practice and Community Medicine Pub Date : 2018-09-04 DOI:10.5530/jppcm.2018.3.31

Jayesh Bhatt, M. Krishnappa, D. Parmar

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引用次数: 0

摘要

最近，“篮子试验”的概念，即在多种适应症中测试单一药物的效果，正受到越来越多的关注。[1]这一概念能否外推到生物仿制药的临床开发中?大多数监管机构都有基于外推概念批准一种或多种附加适应症的生物仿制药的规定，而不必在这些适应症中进行试验。[2-4]阅读更多

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Phase IV Clinical Trials of Biosimilars for Cancer: Extrapolation of the ‘Basket Concept’ of Trials

Of late, the concept of ‘basket trials’, testing the effect of a single drug in multiple indications is receiving increased attention.[1] Can this concept be extrapolated to the clinical development of biosimilars? Majority of the regulatory agencies have the provision for the approval of biosimilars for one or more additional indications based on the concept of extrapolation without necessarily conducting trials in those indications.[2-4] Read More

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Journal of Pharmacy Practice and Community Medicine

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