Регуляторные исследования и экспертиза лекарственных средств (Feb 2018)
Interchangeability of glibenclamide-containing drugs
Abstract
The article analyses the problem of interchangeability of glibenclamide-containing drugs that sometimes lack therapeutic equivalence even though their bioequivalence has been proven. The authors formulated the key factors affecting interchangeability of glibenclamide drugs and highlighted conditions that compromise interchangeability. Special attention was given to clinical pharmacology of glibenclamide and adverse reactions associated with sulfonylurea products. The article offers a summary of the main groups of glibenclamide drugs. It also substantiates the need for better coordination of production and clinical use of glibenclamide drugs which will help to ensure the comparability of generic and reference glibenclamide drugs in the long run.