Munk A
Fakultät für Mathematik, Ruhr-Universität Bochum, D-44780 Bochum, Germany.
Stat Med. 2000 Oct 30;19(20):2843-54. doi: 10.1002/1097-0258(20001030)19:20<2843::aid-sim549>3.0.co;2-a.
As pointed out by Anderson and Hauck and others, average bioequivalence does not guarantee that a patient, being on a drug, may switch to a different formulation. The consideration of individual bioequivalence was therefore suggested. We investigate the relationship between these concepts and show how the standard test for average bioequivalence is related to the assessment of individual bioequivalence. This leads to a guide of when this test becomes inappropriate.
正如安德森、豪克等人所指出的，平均生物等效性并不能保证正在服用某种药物的患者可以换用不同的制剂。因此有人提出了个体生物等效性的考量。我们研究了这些概念之间的关系，并展示了平均生物等效性的标准测试与个体生物等效性评估之间的关联。这得出了该测试何时变得不适用的指南。
