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RegisterEMA: No biowaivers for NTIDs [Dissolution / BCS / IVIVC]
posted by Helmut 
– Vienna, Austria, 2020-07-15 21:08 (1373 d 19:17 ago) – Posting: # 21704
Views: 3,333
Hi dshah,
Why don’t you simply tell us that the drug is rivaroxaban?
Fine. Though there is no product-specific guidance for rivaroxaban publishd by the EMA, most people would consider it an NTID indeed. Following the logic of other NTID-guidances that would mean acceptance limits of 80.00–125.00% for Cmax and 90.00–111.11% for AUC. In rare cases the limits of Cmax have to narrowed as well. Up to you to provide a justification.
Biowaivers for NTIDs are not acceptable. BE-Guideline APPENDIX III:
❝ 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.
Why don’t you simply tell us that the drug is rivaroxaban?
❝ For EMA- A fed study on highest strength and a fasting study on another mid strength is concluded based on guideline.
Fine. Though there is no product-specific guidance for rivaroxaban publishd by the EMA, most people would consider it an NTID indeed. Following the logic of other NTID-guidances that would mean acceptance limits of 80.00–125.00% for Cmax and 90.00–111.11% for AUC. In rare cases the limits of Cmax have to narrowed as well. Up to you to provide a justification.
❝ For waiver request for other strength we need acceptable in vitro dissolution testing of all strengths.
Biowaivers for NTIDs are not acceptable. BE-Guideline APPENDIX III:
Applying for a BCS-based biowaiver is restricted to highly soluble drug substances with known human absorption and considered not to have a narrow therapeutic index.
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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:
- Biowaiver for lower strength using different OGD media dshah 2020-07-13 08:09
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- EMA: No biowaivers for NTIDsHelmut 2020-07-15 19:08
- EMA: No biowaivers for NTIDs Relaxation 2020-07-16 10:54
- Biowaiver only for BCS I and – under certain conditions – BCS III drugs Helmut 2020-07-16 11:27
- 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 dshah 2020-07-17 06:27
- Additional Strength Biowaiver Requirements Obinoscopy 2020-07-18 03:13
- 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 NTIDsHelmut 2020-07-15 19:08
Ing. Helmut Schütz