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RegisterHarmonization of BE study [Regulatives / Guidelines]
Request for discussion on harmonization of BE study in US and EU
Many a times the Innovator (RLD) is manufactured at one site with same qualitative composition and other physical parameters. But as per my knowledge when the generic company wanted to file the products to US and EU, they usually study separate BE study for US and EU with the respective country RLD (nothing but same). Request all to comment on same.
Many a times the Innovator (RLD) is manufactured at one site with same qualitative composition and other physical parameters. But as per my knowledge when the generic company wanted to file the products to US and EU, they usually study separate BE study for US and EU with the respective country RLD (nothing but same). Request all to comment on same.
Complete thread:
- Harmonization of BE studyshyam_5p 2012-01-03 09:05
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- FDA vs. EMA (“same” reference?) Helmut 2012-01-03 14:13
Ing. Helmut Schütz