Learn and Confirm, Inc., St-Laurent, Quebec, Canada.
Faculté de Pharmacie, University of Montreal, Montreal, Quebec, Canada.
Clin Pharmacol Ther. 2019 Feb;105(2):350-362. doi: 10.1002/cpt.1270. Epub 2019 Jan 8.
The science of bioequivalence and biosimilarity has greatly evolved over the past 3 decades. Current methods for assessing bioequivalence mostly rely on noncompartmental pharmacokinetic (PK) analyses, which have proven to be reliable and robust for most products. However, the development of more complex products is forcing scientists and regulators to consider alternative approaches, including those derived from model-based population PK analyses. This article will examine the strengths and weaknesses of standard noncompartmental methods and compare them to model-based approaches, including a comparison of metrics associated with each method. Specific situations for which model-based approaches could prove to be more suitable will be presented, as well as potential bioequivalence metrics that could be considered for bioequivalence comparisons. The opportunities and challenges that are associated with these novel methods will also be discussed.
生物等效性和生物相似性的科学在过去的 30 年里有了很大的发展。目前评估生物等效性的方法主要依赖于非房室药代动力学（PK）分析，这些方法已被证明对大多数产品是可靠和稳健的。然而，更复杂产品的开发迫使科学家和监管机构考虑替代方法，包括基于模型的群体 PK 分析。本文将考察标准非房室方法的优缺点，并将其与基于模型的方法进行比较，包括比较每种方法相关的指标。本文还将介绍基于模型的方法可能更适用的具体情况，以及可用于生物等效性比较的潜在生物等效性指标。本文还将讨论这些新方法带来的机遇和挑战。
