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Registerphenytoin sodium BE study [Regulatives / Guidelines]
Dear jagankm
If you have two different formulation with several strengths each then you have to perform for each formulation one BE study with the highest strength, i.e. according to your example formulation A with 100 mg and formulation B with 300 mg and for the other strengths you can apply a biowaiver.
Kind regards
Dan
If you have two different formulation with several strengths each then you have to perform for each formulation one BE study with the highest strength, i.e. according to your example formulation A with 100 mg and formulation B with 300 mg and for the other strengths you can apply a biowaiver.
Kind regards
Dan
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Kind regards and have a nice day
Dr_Dan
Kind regards and have a nice day
Dr_Dan
Complete thread:
- phenytoin sodium BE study jagankm 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 studyDr_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