But that may not be a good gauge of how large populations of sick patients will tolerate or respond to a variant of the medication they've already been on, say critics of the approval process.

但有批评者认为，仿制药审批过程中采用如此测定方法并不科学，无法估测到有多少体质虚弱的患者无法耐受仿制药与原研药物之间存在的差异。