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Dear Outlaw Torn,
If we were to go through well-established use route and if a BE study is required, what will be the comparator product? Only generics are available as the reference is not available globally.
Though not applicable in my case, how do we find the global development of a product other than the MAH. Sometimes the products are approved in different countries at different times.....different batch numbers.....different manufacturing process. I know a product which is approved in the EU and is still under assessment in the US.
If we were to go through well-established use route and if a BE study is required, what will be the comparator product? Only generics are available as the reference is not available globally.
Though not applicable in my case, how do we find the global development of a product other than the MAH. Sometimes the products are approved in different countries at different times.....different batch numbers.....different manufacturing process. I know a product which is approved in the EU and is still under assessment in the US.
Complete thread:
- Reference Product decision Tina 2013-04-22 11:40 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- EEA: Reference Product Helmut 2013-04-22 13:09
- Reference Product Tina 2013-09-24 14:08
- Reference Product Helmut 2013-09-24 22:53
- Reference Product Tina 2013-09-27 18:02
- Last time: R = innovator Helmut 2013-09-28 09:40
- Reference Product The Outlaw Torn 2013-09-30 08:18
- Reference ProductTina 2013-10-01 14:27
- Reference Product The Outlaw Torn 2013-10-02 08:03
- Reference Product Tina 2013-10-03 11:37
- Reference Product The Outlaw Torn 2013-10-02 08:03
- Reference ProductTina 2013-10-01 14:27
- Reference Product Tina 2013-09-27 18:02
- Reference Product Helmut 2013-09-24 22:53
- Reference Product Tina 2013-09-24 14:08
- EEA: Reference Product Helmut 2013-04-22 13:09
Ing. Helmut Schütz