Generic Products of Antiepileptic Drugs (AEDs): Is It an Issue?

摘要: The availability of generic products antiepileptic drugs (AEDs) has raised the following concerns: (1) Do AEDs work as well brand in terms their efficacy, safety and quality? (2) Can be used substitutions for AEDs? (3) interchangeably? traditional average bioequivalence analysis addresses concern 1 but does not provide a complete adequate response to concerns 2 3. Drug interchangeability can classified drug prescribability or switchability. refers situation where patient is treated first time so that either bioequivalent AED chosen. switchability which switched product same AED. approach sufficient evaluate products, ensure between prescribable formulations. necessity assuring two formulations addressed by individual bioequivalence. While switch tolerated many patients general cost-effective, seizure control should sacrificed on basis cost alone, major end point treating epilepsy with without side effects. Until we have (within patient) data and/or tools priori identify subset susceptible switch, seizure-free recommended.