Wilding Ian
Pharmaceutical Profiles, Ltd., Ruddington, Nottingham, United Kingdom.
J Clin Pharmacol. 2002 Nov;42(11):1200-10. doi: 10.1177/009127002762491280.
Bioequivalence testing for locally acting gastrointestinal products is a challenging issue for both the pharmaceutical industry and the global regulatory authorities. It is widely accepted that for medicinal products not intended to be delivered into the systemic circulation, pharmacokinetic bioavailability cannot be used. However, it is becoming increasingly accepted that local availability may be assessed, where appropriate, by approaches that qualitatively reflect the presence of the active substance at the site of action. These methods must be specifically chosen for that combination of active substance and route of drug delivery. This paper argues for the use of gamma scintigraphy as a validated measure of local availability and bioequivalence for topically acting products administered to the gastrointestinal tract by the oral and rectal route.
对于局部作用的胃肠道产品进行生物等效性测试，对制药行业和全球监管机构而言都是一个具有挑战性的问题。人们普遍认为，对于无意进入体循环的药品，不能采用药代动力学生物利用度。然而，越来越多的人接受，在适当情况下，可以通过定性反映活性物质在作用部位存在情况的方法来评估局部可用性。这些方法必须针对活性物质和药物递送途径的组合进行专门选择。本文主张将γ闪烁显像法用作经口服和直肠途径给药至胃肠道的局部作用产品的局部可用性和生物等效性的验证方法。
