On hybrid parallel-crossover designs for assessing drug interchangeability of biosimilar products
On hybrid parallel-crossover designs for assessing drug interchangeability of biosimilar products
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DOI：
10.1080/10543406.2017.1275956
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发表时间：
2017-01-01
影响因子：
1.1
通讯作者：
Cui, Can
中科院分区：
文献类型：
--
作者：
Chow, Shein-Chung;Song, Fuyu;Cui, Can
近年来，一种由R-R和R-T-R-T两个处理序列组成的特定混合平行交叉设计被提出并受到广泛关注，其中T和R分别是建议的生物相似产品和创新的生物产品，用于评价T和R之间的药物互换性，其中R可以是美国许可的产品或欧盟参考产品。在实践中，有三种类型的混合平行交叉设计通常用于评估生物相似产品的药物互换性。这三种类型的并行-交叉混合设计包括(1)并行+2×2交叉设计，(2)并行+2×3交叉设计，以及(3)并行+2×4交叉设计。本文对这些研究设计进行了全面的综述，包括一项完整的N-of-1随机试验设计。讨论了一种特殊的混合并行交叉设计，即(RRRR，RTRT)，用于解决药物互换性和有/无交替之间的相对风险。
In recent years, a specific hybrid parallel-crossover design that consists of two sequences of treatments, namely R-R-R-R and R-T-R-T, where T and R is a proposed biosimilar product and an innovative biological product, respectively, have been proposed and received much attention for assessing drug interchangeability between T and R, where R could be either a US-licensed product or an EU-reference product. In practice, there are three types of hybrid parallel-crossover designs that are commonly employed in assessing drug interchangeability of biosimilar products. These three types of parallel-crossover hybrid designs include (1) a parallel + 2 x 2 crossover design, (2) a parallel + 2 x 3 crossover design, and (3) a parallel + 2 x 4 crossover design. This article provides a comprehensive review of these study designs including a complete N-of-1 randomized trial design. A specific hybrid parallel-crossover design, that is, (RRRR, RTRT) for addressing drug interchangeability in terms of switching and the relative risk between with/without alternation is discussed.