Solubility based Biowaiver [Dissolution / BCS / IVIVC]

posted by The Outlaw Torn – Europe, 2018-10-02 09:51 (1089 d 19:35 ago) – Posting: # 19361
Views: 4,877

» 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".

Where is the difference coming from?

Is the API less than 5% of the total weight of the tablet?

Take a look at the General biowaiver criteria on page 12 of the guideline. If you don't meet the conditions stated in c), you'll need to conduct a BE study at the lower strength too.

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