Pentosan Polysulfate Sodium Bioequivalence study [Regulatives / Guidelines]

posted by Maitri – India, 2019-05-31 06:33  – Posting: # 20307
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» If a drug exhibits limited absorption but is highly soluble you could perform a BCS class III biowaiver. But to my knowledge this does not apply to pentosan polysulfate.

Hi Dan,
You mentioned that BCS III based biowaiver does not apply to Pentosan Polysulfate Sodium, Can you please explain why?
Maitri


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[Helmut]

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