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RegisterBiowaiver for lower strength using different OGD media [Dissolution / BCS / IVIVC]
Greetings All!
Hope all are doing well and are safe in this pandemic condition.
We are working on a NTI drug with high variability for which different dissolution media is recommended by USFDA.
For BE study as per USFDA- a fasting and fed study for highest strength is recommended.
For EMA- A fed study on highest strength and a fasting study on another mid strength is concluded based on guideline.
For waiver request for other strength we need acceptable in vitro dissolution testing of all strengths. Generally media for lower and higher strength are same but in my condition, due to solubility limitations, highest strength's dissolution is recommended with 0.45% SDS, a mid range strength's dissolution with 0.2% SDS and lower strength dissolution using no surfactant are recommended.
A screenshot is attached for reference.![[image]](img/uploaded/image216.jpg)
In such condition- how to prove F2 value>50 for rest of the strength because recommended media are different?
Regards,
Shah
Hope all are doing well and are safe in this pandemic condition.
We are working on a NTI drug with high variability for which different dissolution media is recommended by USFDA.
For BE study as per USFDA- a fasting and fed study for highest strength is recommended.
For EMA- A fed study on highest strength and a fasting study on another mid strength is concluded based on guideline.
For waiver request for other strength we need acceptable in vitro dissolution testing of all strengths. Generally media for lower and higher strength are same but in my condition, due to solubility limitations, highest strength's dissolution is recommended with 0.45% SDS, a mid range strength's dissolution with 0.2% SDS and lower strength dissolution using no surfactant are recommended.
A screenshot is attached for reference.
In such condition- how to prove F2 value>50 for rest of the strength because recommended media are different?
Regards,
Shah
Complete thread:
- Biowaiver for lower strength using different OGD mediadshah 2020-07-13 08:09 [Dissolution / BCS / IVIVC]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
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- Additional strength Biowaiver wienui 2020-07-18 18:00
- Biowaiver only for BCS I and – under certain conditions – BCS III drugs dshah 2020-07-17 06:27
- Biowaiver only for BCS I and – under certain conditions – BCS III drugs Obinoscopy 2020-07-16 14:36
- Biowaiver only for BCS I and – under certain conditions – BCS III drugs Helmut 2020-07-16 11:27
- EMA: No biowaivers for NTIDs Relaxation 2020-07-16 10:54
- EMA: No biowaivers for NTIDs Helmut 2020-07-15 19:08
Ing. Helmut Schütz