Pentosan Polysulfate Sodium Bioequivalence study [Regulatives / Guidelines]

posted by ramesh_7779  – 2010-09-23 06:41  – Posting: # 5932
Views: 5,597

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:

Activity
 Mix view
Bioequivalence and Bioavailability Forum |  Admin contact
19,688 posts in 4,178 threads, 1,353 registered users;
online 9 (0 registered, 9 guests [including 6 identified bots]).
Forum time (Europe/Vienna): 10:02 CEST

Power. That which statisticians are always calculating
but never have.    Stephen Senn

The BIOEQUIVALENCE / BIOAVAILABILITY FORUM is hosted by
BEBAC Ing. Helmut Schütz
HTML5