Bioequivalence and Bioavailability Forum

Hi Helmut,

❝ ❝ […] FDA is a bit strange. They ask for EtOH in-vitro dose dumping test on drugs liable for abuse like Methylphenidate ER (Concerta, Ritalin, Metadate) but not with Amphetamine ER (Adderall XR).

❝

❝ That’s bizarre. I estimate the potential for abuse higher than for MPH.

See FDA Amphetamine ER Draft Guidance

I find it strange too like you said it's one of the drugs. I wonder if the tests for EtOH effect on these products were actually brought up by the innovators instead of the agency. I mean the innovator convinced the agency with a) their products are alcohol resistance, b) safety & abuse issues. But if it's not on the guidance then I guess no one would even bother testing it.

❝ If the alcohol effect cannot be avoided and it is present also in the reference product, the applicant should justify / demonstrate that it lacks of clinical relevance.

Haha, applicable to Amphetamine? Lack of recreational relevance? I don't get it. If the reference product has EtOH effect, then why would the generics need to justify if theirs also have EtOh effect (not a fair game)?

Thanks

John