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RegisterBE waiver for tablet after reducing % of API [Dissolution / BCS / IVIVC]
Dear ALL
I am new to this forum and searched this forum as I want to get some information.
I am working on one generic tablet product in which API has been used 104% after seeing the stability data and from the previous information available. For 104% we have established bioequivalence with the innovator.
I do not know whether innovator/originator has 104% or 100%
Now If I make a formulation which having 100% API is it possible to avoid bioequivalence with the same excipients as the previous formulation or with he different excipients as the previous formulation.
Thanks in Advance
Gary
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Edit: Category changed. [Helmut]
I am new to this forum and searched this forum as I want to get some information.
I am working on one generic tablet product in which API has been used 104% after seeing the stability data and from the previous information available. For 104% we have established bioequivalence with the innovator.
I do not know whether innovator/originator has 104% or 100%
Now If I make a formulation which having 100% API is it possible to avoid bioequivalence with the same excipients as the previous formulation or with he different excipients as the previous formulation.
Thanks in Advance
Gary
--
Edit: Category changed. [Helmut]
Complete thread:
- BE waiver for tablet after reducing % of APIg.sharma 2009-05-19 14:47
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- BE waiver for tablet after reducing % of API Helmut 2009-05-19 15:25
- BE waiver for tablet after reducing % of API g.sharma 2009-05-19 16:59
- BE waiver for tablet after reducing % of API Helmut 2009-05-19 19:29
- BE waiver for tablet after reducing % of API g.sharma 2009-05-20 09:55
- BE waiver for tablet after reducing % of API Helmut 2009-05-19 19:29
- BE waiver for tablet after reducing % of API g.sharma 2009-05-19 16:59
- BE waiver for tablet after reducing % of API Helmut 2009-05-19 15:25
Ing. Helmut Schütz