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Registersame drug substance, 2 brands with different strengths [Regulatives / Guidelines]
Dear all,
This is my first post and I did a search before posting. the similar topic with my question is (http://forum.bebac.at/mix_entry.php?id=6772#p6772),but mine is absolutely not the same.
Get down to the business,I have a problem, we would like to submit a ANDA in Germany, but the RLD (R) has 4 strengths, and the lowest stength(R1) has a different brand name(AOO) with the other 3 Strengths (AOB). If the dissolution of AOO is different with AOB.
Whether we should conduct 2 BE studies with the lowest strength and the highest strength?
and if we can make our the dissolution of our 4 preparations the same, can we only conduct one BE Study with the highest strength?
Can anyone give some reference/guideline to me in detail? Thanks a million.
Abby
This is my first post and I did a search before posting. the similar topic with my question is (http://forum.bebac.at/mix_entry.php?id=6772#p6772),but mine is absolutely not the same.
Get down to the business,I have a problem, we would like to submit a ANDA in Germany, but the RLD (R) has 4 strengths, and the lowest stength(R1) has a different brand name(AOO) with the other 3 Strengths (AOB). If the dissolution of AOO is different with AOB.
Whether we should conduct 2 BE studies with the lowest strength and the highest strength?
and if we can make our the dissolution of our 4 preparations the same, can we only conduct one BE Study with the highest strength?
Can anyone give some reference/guideline to me in detail? Thanks a million.
Abby
Complete thread:
- same drug substance, 2 brands with different strengthswanabby 2012-03-08 04:52
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