Solubility based Biowaiver [Dissolution / BCS / IVIVC]

posted by Amalia – Greece, 2018-10-02 10:35 (847 d 04:01 ago) – Posting: # 19362
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» Where is the difference coming from?

None of the excipients are proportional.

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

The API of the lowest strength is less than 5%. But not of the highest strength for which a BE study was performed.

» 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.

I Know. The most probable scenario is that we will perform a BE study. We are just trying to see if a justification can be made.


Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5! Please follow the Forum’s Policy[Helmut]

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