生物仿制药
关键质量属性
食品药品监督管理局
产品(数学)
质量(理念)
计算机科学
相似性(几何)
新产品开发
风险分析(工程)
医学
数学
业务
生物技术
营销
人工智能
生物
认识论
图像(数学)
哲学
几何学
作者
Shein‐Chung Chow,Fuyu Song
摘要
For regulatory review and approval of biosimilar products, the United States ( US ) Food and Drug Administration ( FDA ) recommended a stepwise approach for demonstrating biosimilarity between a proposed biosimilar product and an innovative (reference) biological product (e.g., an US ‐licensed product). 1–3 The stepwise approach is to provide totality‐of‐the‐evidence for demonstrating biosimilarity between the proposed biosimilar product and the reference product. The stepwise approach starts with analytical studies for functional and structural characterization of critical quality attributes ( CQAs ) at various stages of manufacturing process. For the assessment of analytical similarity of CQAs , FDA suggests, first, identifying the CQAs that are relevant to clinical outcomes, and then classifying the identified CQAs into several tiers depending upon their criticality or risk ranking. FDA also suggests different methods be used to assess similarity for CQAs from different tiers. For example, equivalence test for CQAs from Tier 1, quality range approach for CQAs from Tier 2, and descriptive raw data and graphical comparison for CQAs from Tier 3. In this article, controversial issues regarding the FDA ’s recommended approaches are discussed followed by alternative methods for assessment of similarity for CQAs from Tier 1. WIREs Comput Stat 2017, 9:e1407. doi: 10.1002/wics.1407 This article is categorized under: Applications of Computational Statistics > Clinical Trials
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