Generic_AED_Products_in_the_treatment_of_epilepsy_in_Europe.ppt

* Conflicting reports regarding therapeutic equivalence bioequivalence of brand generic CBZ products Con: Sachdeo et al, Lancet, 1987 Epilepsia, 1987: Breakthrough seizure due to a switch to generics Pro: Richens, CNS Drugs, 1997: Bioequivalence is a negligible source for variation in therapeutic response Pros Cons for Generic CBZ * Against a Switch to Generic PHT PHT is a highly variable drug with nonlinear PK a narrow therapeutic window PHT has been utilized as a weapon against generic AEDs with linear PK (VPA, CBZ, LTG) * Bioequivalence Generic AEDs Problems with generic AED