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Registerphenytoin sodium BE study [Regulatives / Guidelines]
Dear All,
WE are generic pharmaceuticals developing phenytoin sodium capsules in the concentration of 25 -300mg (dose proportional)for Uk submission.
The query is regarding BE study strength.
as phenytoin is nonlinear pharmacokinetic drug. As per EMEA guidance we can show bioequivalence for higher strength (300 mg) and can apply Biowaiver for remaining strenghts.
we are in ambiquity to decide correct BE strength. kindly advice.
WE are generic pharmaceuticals developing phenytoin sodium capsules in the concentration of 25 -300mg (dose proportional)for Uk submission.
The query is regarding BE study strength.
as phenytoin is nonlinear pharmacokinetic drug. As per EMEA guidance we can show bioequivalence for higher strength (300 mg) and can apply Biowaiver for remaining strenghts.
we are in ambiquity to decide correct BE strength. kindly advice.
Complete thread:
- phenytoin sodium BE studyjagankm 2012-04-24 11:54 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- phenytoin sodium BE study Dr_Dan 2012-04-25 12:25
- phenytoin sodium BE study jagankm 2012-04-26 06:17
- phenytoin sodium BE study Dr_Dan 2012-04-26 15:54
- phenytoin sodium BE study jagankm 2012-04-26 06:17
- phenytoin sodium BE study Dr_Dan 2012-04-25 12:25
Ing. Helmut Schütz