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RegisterSolubility based Biowaiver [Dissolution / BCS / IVIVC]
Do as others have said, Amalia.
Follow section 4.2 of the Guideline. When it points you to appendix III, ignore the BCS-biowaiver stuff. Focus on the first third of the information on page 27 only (about experimental conditions). In other words, don't think BCS or solubility or permeability or API or anything else. Do the standard comparative dissolution testing at 3 pH values for your finished drug product at all strengths, etc.
Follow section 4.2 of the Guideline. When it points you to appendix III, ignore the BCS-biowaiver stuff. Focus on the first third of the information on page 27 only (about experimental conditions). In other words, don't think BCS or solubility or permeability or API or anything else. Do the standard comparative dissolution testing at 3 pH values for your finished drug product at all strengths, etc.
Complete thread:
- Solubility based Biowaiver Amalia 2018-10-01 11:04 [Dissolution / BCS / IVIVC]
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Ing. Helmut Schütz