Pentosan Polysulfate Sodium Bioequivalence study [Regulatives / Guidelines]

posted by ramesh_7779  – 2010-09-23 08:41 (5256 d 16:39 ago) – Posting: # 5932
Views: 9,410

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

Complete thread:

UA Flag
Activity
 Admin contact
23,380 posts in 4,914 threads, 1,661 registered users;
38 visitors (0 registered, 38 guests [including 2 identified bots]).
Forum time: 00:20 CET (Europe/Vienna)

Skill is a function of chance.
It’s an intuitive best-use of chance situations.    Philip K. Dick

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5