ramesh_7779
★    

2010-09-23 06:41

Posting: # 5932
Views: 5,723
 

 Pentosan Polysulfate Sodium Bioequivalence study [Regulatives / Guidelines]

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 ([image] policy_bureau_enquires[image]hc-sc.gc.ca[) regarding the Canadian requirements for subsequent market entry pentosan polysulfate sodium immediate release capsules.

As per the above reference they are advising to do pharmacodynamic studies. If any reference available please guide me.

Rgds
Raja
Dr_Dan
★★  

2010-09-23 11:26

@ ramesh_7779
Posting: # 5933
Views: 5,017
 

 Pentosan Polysulfate Sodium Bioequivalence study

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 07:20

@ Dr_Dan
Posting: # 5934
Views: 4,578
 

 Pentosan Polysulfate Sodium Bioequivalence study

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
★★  

2010-09-24 11:58

@ ramesh_7779
Posting: # 5935
Views: 4,666
 

 Pentosan Polysulfate Sodium Bioequivalence study

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 06:33

@ Dr_Dan
Posting: # 20307
Views: 691
 

 Pentosan Polysulfate Sodium Bioequivalence study

» 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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