Solubility based Biowaiver [Dissolution / BCS / IVIVC]

posted by Amalia – Greece, 2018-10-02 08:59  – Posting: # 19360
Views: 2,819

Dear Obinoscopy,

what I guess I should have clarified is that the reason we are trying to use this justification is because the lower strength is not proportional in terms of excipients.

» The advise was given by an "external clinical expert".

I presume this is why we were advised to follow the solubility path for a biowaiver? That is why we are wondering whether we should perform the solubility tests at the API or the final formulation.
What do you think?

Kind Regards,

Amalia

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