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Register'BE' to innovator's product which is not RLD [Design Issues]
posted by Helmut 
– Vienna, Austria, 2007-03-18 14:21 (7037 d 09:35 ago) – Posting: # 585
Views: 3,980
Dear ioanam!
Since your drug is not dose proportional, and I don't expect it will be an realistic option to administer the lowest common multiple (480mg) of test (4×120mg) and RLD (3×160mg), IMHO it would make sense to go for a comparative BA with the other innovator's 120mg formulation.
Such a procedure is not BE in FDA's sense (reference not the RLD); you must contact CDER/OGD's review staff first!
Since your drug is not dose proportional, and I don't expect it will be an realistic option to administer the lowest common multiple (480mg) of test (4×120mg) and RLD (3×160mg), IMHO it would make sense to go for a comparative BA with the other innovator's 120mg formulation.
Such a procedure is not BE in FDA's sense (reference not the RLD); you must contact CDER/OGD's review staff first!
—
Dif-tor heh smusma 🖖🏼 Довге життя Україна!![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png)
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:
- different strength ioanam 2007-03-18 00:27
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- 'BE' to innovator's product which is not RLDHelmut 2007-03-18 13:21
Ing. Helmut Schütz