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RegisterPentosan Polysulfate Sodium Bioequivalence study [Regulatives / Guidelines]
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
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
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Kind regards and have a nice day
Dr_Dan
Kind regards and have a nice day
Dr_Dan
Complete thread:
- Pentosan Polysulfate Sodium Bioequivalence study ramesh_7779 2010-09-23 06:41
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- Pentosan Polysulfate Sodium Bioequivalence studyDr_Dan 2010-09-23 11:26
- Pentosan Polysulfate Sodium Bioequivalence study ramesh_7779 2010-09-24 07:20
- Pentosan Polysulfate Sodium Bioequivalence study Dr_Dan 2010-09-24 11:58
- Pentosan Polysulfate Sodium Bioequivalence study Maitri 2019-05-31 06:33
- Pentosan Polysulfate Sodium Bioequivalence study ramesh_7779 2010-09-24 07:20
- Pentosan Polysulfate Sodium Bioequivalence studyDr_Dan 2010-09-23 11:26
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