Pentosan Polysulfate Sodium Bioequivalence study [Regulatives / Guidelines]

posted by ramesh_7779  – 2010-09-23 06:41  – Posting: # 5932
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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

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