Solubility based Biowaiver [Dissolution / BCS / IVIVC]

posted by Obinoscopy  – USA, 2018-10-01 15:03 (1090 d 13:48 ago) – Posting: # 19352
Views: 4,911

Dear Amalia,

There are basically two biowaiver pathways. One is Additional Strength Biowaivers while the other is BCS-Based Biowaivers. Which pathway do you intend following?

If BCS, then you need to first classify your API as to whether it's BCS Class I or Class III. this will require performing the prescribed experiment or referring to literature as spelt out in the guideline.

It is then that you can now demonstrate dissolution rate of your FPP (in 15 or 30 minutes) and then go ahead with comparative dissolution studies. The classification determines the dissolution requirements for your FPP.



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