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RegisterBE waiver for tablet after reducing % of API [Dissolution / BCS / IVIVC]
Dear Helmut
I want to reformulate as my company has submitted this to regulatory authorities and they have asked the reasons for overages.
Moreover my company wants to reformulate it without overage and with only 100%API.
I want to know if it is possible to avoid bioequivalence study of tablet if we reduce % of API and how much percentage of variability is allowed.
please tell if there is any european or ICH guideline to this issue.
Thanks in advance
Edit: Full quote removed. Please delete anything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Helmut]
I want to reformulate as my company has submitted this to regulatory authorities and they have asked the reasons for overages.
Moreover my company wants to reformulate it without overage and with only 100%API.
I want to know if it is possible to avoid bioequivalence study of tablet if we reduce % of API and how much percentage of variability is allowed.
please tell if there is any european or ICH guideline to this issue.
Thanks in advance
Edit: Full quote removed. Please delete anything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Helmut]
Complete thread:
- BE waiver for tablet after reducing % of API g.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 APIg.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 APIg.sharma 2009-05-19 16:59
- BE waiver for tablet after reducing % of API Helmut 2009-05-19 15:25
Ing. Helmut Schütz