Solubility based Biowaiver [Dissolution / BCS / IVIVC]
❝ 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.
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❝ ❝ 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.
Complete thread:
- Solubility based Biowaiver Amalia 2018-10-01 11:04
- Solubility based Biowaiver Obinoscopy 2018-10-01 15:03
- Solubility based Biowaiver Amalia 2018-10-01 15:59
- Solubility based Biowaiver Obinoscopy 2018-10-01 19:05
- Solubility based Biowaiver wienui 2018-10-02 04:52
- Solubility based Biowaiver Amalia 2018-10-02 08:59
- Solubility based BiowaiverThe Outlaw Torn 2018-10-02 09:51
- Solubility based Biowaiver Amalia 2018-10-02 10:35
- Solubility based Biowaiver Obinoscopy 2018-10-06 19:59
- Solubility based BiowaiverThe Outlaw Torn 2018-10-02 09:51
- Solubility based Biowaiver The Outlaw Torn 2018-10-02 08:56
- Solubility based Biowaiver Obinoscopy 2018-10-01 19:05
- Solubility based Biowaiver Amalia 2018-10-01 15:59
- Solubility based Biowaiver lukamar 2018-10-05 09:30
- Solubility based Biowaiver Obinoscopy 2018-10-01 15:03