Ansbacher R
Department of Obstetrics and Gynecology, University of Michigan Medical Center, Ann Arbor 48109-0718.
Contraception. 1991 Feb;43(2):139-47. doi: 10.1016/0010-7824(91)90041-d.
Current Food and Drug Administration guidelines for assessing the differences in bioavailability between generic oral contraceptives and brand-name products are inadequate to ensure therapeutic equivalence. The guidelines do not take into account those women who may have blood levels of active ingredients well outside the range of acceptability. Due to the narrow therapeutic range of steroids, these women may become pregnant or experience an increased incidence of breakthrough bleeding. Furthermore, oral contraceptive packaging is unique to each manufacturer, and any change in brands (and therefore packaging) can easily negate the sequential administration of the appropriate tablet. These are among the reasons proposed for placing oral contraceptives in the critical drug category, in which generic substitution and interchangeability of products should not be allowed.
美国食品药品监督管理局目前关于评估非专利口服避孕药与品牌产品生物利用度差异的指导方针，不足以确保治疗等效性。这些指导方针没有考虑到那些体内活性成分血液水平可能远超出可接受范围的女性。由于类固醇的治疗范围狭窄，这些女性可能会怀孕或突破性出血的发生率增加。此外，每个制造商的口服避孕药包装都是独特的，品牌（以及因此包装）的任何变化都可能轻易否定适当片剂的顺序服用。这些是提议将口服避孕药列入关键药物类别的部分原因，在该类别中不应允许产品的非专利替代和互换。
