ramesh_7779 ★ 2010-09-23 08:41 (5256 d 17:32 ago) Posting: # 5932 Views: 9,412 |
|
Dear All, Please tell me whether it is possible to do bioequivalence study for Pentosan Polysulfate Sodium. As this the low Mwt and as per this This letter responds to your April 4, 2008 email query addressed to Policy Bureau Enquires ( ![]() ![]() As per the above reference they are advising to do pharmacodynamic studies. If any reference available please guide me. Rgds Raja |
Dr_Dan ★★ Germany, 2010-09-23 13:26 (5256 d 12:46 ago) @ ramesh_7779 Posting: # 5933 Views: 8,132 |
|
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 |
ramesh_7779 ★ 2010-09-24 09:20 (5255 d 16:53 ago) @ Dr_Dan Posting: # 5934 Views: 7,638 |
|
Dear Dr Dan, Thanks for the reply. if you can provide any reference for Pentosan Polysulfate Sodium, it will be helpful. Rgds Raja |
Dr_Dan ★★ Germany, 2010-09-24 13:58 (5255 d 12:14 ago) @ ramesh_7779 Posting: # 5935 Views: 7,835 |
|
Dear Raja try this one: Simon M, McClanahan RH, Shah JF et al. Metabolism of [3H]pentosan polysulfate sodium (PPS) in healthy human volunteers. Xenobiotica. 2005 Aug;35(8):775-84 Hope this helps. Kind regards Dan — Kind regards and have a nice day Dr_Dan |
Maitri ☆ India, 2019-05-31 08:33 (2084 d 17:39 ago) @ Dr_Dan Posting: # 20307 Views: 3,763 |
|
❝ 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] |