Pentosan Polysulfate Sodium Bioequivalence study [Regulatives / Guidelines]

posted by Dr_Dan  – 2010-09-23 11:26 (3815 d 19:15 ago) – Posting: # 5933
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Dear Raja
In fact you can not perform a bioequivalence study if the drug is not systemically available due to very poor resorption (Bioavailability 0.4 - 3%). 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. So the only way to show therapeutic equivalence is to perform a pharmacodynamic or a comparative efficacy study.
Kind regards
Dan

Kind regards and have a nice day
Dr_Dan

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