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RegisterBiowaiver for Capecitabine - FDA x EMA [Dissolution / BCS / IVIVC]
Dear Mauricio
capecitabine is unstable in acidic medium and in the opinion of EMA this does not allow the BCS classification of capecitabine. IMHO this is nonsense or at least no argument against a biowaiver. Stability in acidic media is a substance specific property. The aim of a BE study is to show possible differences in formulation. If both formulation rapidly disintegrate and the API is dissolved within 15 min. what would be the advantage of a BE study? Once dissolved capecitabine from the test formulation would be affected with regard to stability in the same way as capecitabine from the reference formulation, right?
I had the same discussion with a different drug and finally the biowaiver was accepted, but it is a case by case decision. BTW I do not like the EMA product specific bioequivalence recommendations. I think These are not well elaborated.
I hope this helps.
Kind regards
Dr_Dan
capecitabine is unstable in acidic medium and in the opinion of EMA this does not allow the BCS classification of capecitabine. IMHO this is nonsense or at least no argument against a biowaiver. Stability in acidic media is a substance specific property. The aim of a BE study is to show possible differences in formulation. If both formulation rapidly disintegrate and the API is dissolved within 15 min. what would be the advantage of a BE study? Once dissolved capecitabine from the test formulation would be affected with regard to stability in the same way as capecitabine from the reference formulation, right?
I had the same discussion with a different drug and finally the biowaiver was accepted, but it is a case by case decision. BTW I do not like the EMA product specific bioequivalence recommendations. I think These are not well elaborated.
I hope this helps.
Kind regards
Dr_Dan
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Kind regards and have a nice day
Dr_Dan
Kind regards and have a nice day
Dr_Dan
Complete thread:
- Biowaiver for Capecitabine - FDA x EMA Mauricio Sampaio 2015-09-08 20:38
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Biowaiver for Capecitabine - FDA x EMADr_Dan 2015-09-09 09:00
- Biowaiver for Capecitabine - FDA x EMA Mauricio Sampaio 2015-09-09 18:42
- …as well as the solubility Dr_Dan 2015-09-10 08:52
- …as well as the solubility Mauricio Sampaio 2015-09-15 06:56
- regulatory authorities have a different view Dr_Dan 2015-09-15 08:53
- regulatory authorities have a different view Mauricio Sampaio 2015-09-17 06:44
- regulatory authorities have a different view Dr_Dan 2015-09-15 08:53
- …as well as the solubility Mauricio Sampaio 2015-09-15 06:56
- Biowaiver for Capecitabine - FDA x EMADr_Dan 2015-09-09 09:00
Ing. Helmut Schütz