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Hi Everyone,
As per FDA, BE studies for Mixed Amphetamine (Adderall, Adderall XR) requires measurement of both D- and L-amphetamine in the plasma. What about the requirement of 5% difference in relative potency (total Assay) between test and reference product? Does one have to demonstrate that on both D and L forms of amphetamine?
Thanks
John
As per FDA, BE studies for Mixed Amphetamine (Adderall, Adderall XR) requires measurement of both D- and L-amphetamine in the plasma. What about the requirement of 5% difference in relative potency (total Assay) between test and reference product? Does one have to demonstrate that on both D and L forms of amphetamine?
Thanks
John
Complete thread:
- Adderalljag009 2012-05-22 21:31
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Adderall drgunasakaran1 2012-05-31 14:34
Ing. Helmut Schütz