Log in
Registerpermeability testing and biowaiver [Dissolution / BCS / IVIVC]
Hello All,
first of all hats off to dear HS for providing such vibrant platform for BA/BE people.
Now, my question is we can claim biowaiver if the drug is fall in BCS-I class. but how to measure permeability of drug, and is there any regulatory hurdles to get the biowaiver, as i heard it is quite difficult as well as costly exerciese and it is wise to perform BE study rather.
Hope you people understood me well.
Regards,
compliance
first of all hats off to dear HS for providing such vibrant platform for BA/BE people.
Now, my question is we can claim biowaiver if the drug is fall in BCS-I class. but how to measure permeability of drug, and is there any regulatory hurdles to get the biowaiver, as i heard it is quite difficult as well as costly exerciese and it is wise to perform BE study rather.
Hope you people understood me well.
Regards,
compliance
Complete thread:
- permeability testing and biowaiverCompliance 2012-04-28 13:13 [Dissolution / BCS / IVIVC]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- permeability testing and biowaiver drgunasakaran1 2012-04-30 07:09
- permeability testing and biowaiver Dr_Dan 2012-04-30 14:13
- permeability testing and biowaiver jag009 2012-04-30 20:08
Ing. Helmut Schütz