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RegisterBE-Study design recommendations from regulatory authorities [Design Issues]
Dear All,
Greetings!
Just as we receive recommendations from Office of Generic Drugs (OGD) of US-FDA regarding which BE study design to be followed and what in-vitro dissolution criteria to be adopted, does any regulatory authority in EU provides similar recommendations?
Request you to please provide your inputs.
Regards,
Essar
Greetings!
Just as we receive recommendations from Office of Generic Drugs (OGD) of US-FDA regarding which BE study design to be followed and what in-vitro dissolution criteria to be adopted, does any regulatory authority in EU provides similar recommendations?
Request you to please provide your inputs.
Regards,
Essar
Complete thread:
- BE-Study design recommendations from regulatory authoritiesEssar 2006-08-22 09:07
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- BE-Study designs (US vs. EU) Helmut 2006-08-22 15:45
Ing. Helmut Schütz