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RegisterReference Product [Regulatives / Guidelines]
posted by Helmut 
– Vienna, Austria, 2013-09-25 00:53 (4269 d 23:33 ago) – Posting: # 11554
Views: 6,039
Hi Tina,
No. By definition BE is based on a comparative bioavailability study where the reference is the innovator. See this old slide. You have two generics, the first test is BE to the innovator but the second test is not. If you would use the first test as the reference, test 2 would be “bioequivalent”.
In the EU you can show BE for pharmaceutical alternatives as well. No problem.
No way (see above). Even if you want to go for a national application, you can use a reference with a MA in any country of the EEA. If the innovator is not marketed in any member state, bad luck.
❝ Instead of MRP/DCP, if the product were to be marketed only in one country and if the innovator isnt available in that country, are we justified in showing BE with the generic which is available in the country (which has showed BE with the innovator?) and is available in the market for more than 8 years.
No. By definition BE is based on a comparative bioavailability study where the reference is the innovator. See this old slide. You have two generics, the first test is BE to the innovator but the second test is not. If you would use the first test as the reference, test 2 would be “bioequivalent”.
❝ If the innovator product is a capsule and the proposed test are tablets…
In the EU you can show BE for pharmaceutical alternatives as well. No problem.
❝ …if innovator in not available in the proposed country, doing a BE study in the existing generic (tablets ) will reduce formulation (capsule vs tablet) associated any change in the release of the active from the formulation.
No way (see above). Even if you want to go for a national application, you can use a reference with a MA in any country of the EEA. If the innovator is not marketed in any member state, bad luck.
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Helmut Schütz
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Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
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 ProductHelmut 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 Product Tina 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 Product Tina 2013-10-01 14:27
- Reference Product Tina 2013-09-27 18:02
- Reference ProductHelmut 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