Statistical Evaluation of Alternating Ability of Biosimilar Drug Products
Date Issued
2014
Date
2014
Author(s)
Yang, Yu-Ching
Abstract
As more biological products are going off patent protection, the development of biosimilar products has received much attention. Unlike traditional small-molecule chemical drug products, which called generic drug, the development of biologic products is very different from the small-molecule drug products due to the complexity of the molecular structure, complicated manufacturing process and severe immunogenicity reactions.
Several criteria are proposed to evaluate the similarity between the biosimilar product and its reference product. One of these criteria is the alternating ability. Alternative ability means that the biosimilar product may be substituted for the reference product without the intervention of the health care provider who prescribed the reference product. The concept of alternating is referred to as either the switch from test product (T) to its corresponding reference drug (R) and then switch back to T or the switch from R to T and then switch back to R. Thus, the difference between “the switch from T to R” or “the switch from R to T” and “the switch from R to T” or “the switch from T to R” needs to be assessed for addressing the concept of alternating. The concept of alternating ability was formulated as the hypotheses for profile analysis. Then we proposed a multivariate equivalence testing procedure under two sequences and three periods (2 3) crossover design to assess the alternating ability. Simulation studies were conducted to evaluate performance of the proposed procedure in terms of size and power. Numerical example illustrates the proposed procedure. Methods of sample size determination for evaluation of alternating ability under 2 3 crossover design were also proposed.
Subjects
生物製劑
生物製劑相似性藥品
曼哈頓距離
交叉設計
多變量對等性假說
Type
thesis
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