Lamy P P
J Clin Pharmacol. 1986 May-Jun;26(5):309-16. doi: 10.1002/j.1552-4604.1986.tb03531.x.
Critical questions remain concerning many issues involved in the identification of bioequivalent and therapeutically equivalent drugs. They need to be answered, and scientists and clinicians should address these issues, in concert with the FDA, as soon as possible.
关于生物等效性药物和治疗等效性药物鉴定所涉及的许多问题,关键问题依然存在。这些问题需要得到解答,科学家和临床医生应尽快与美国食品药品监督管理局协同解决这些问题。