Pentosan Polysulfate Sodium Bioequivalence study [Regulatives / Guidelines]

posted by Maitri – India, 2019-05-31 06:33 (869 d 16:57 ago) – Posting: # 20307
Views: 2,421

» 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]

Complete thread:

Activity
 Admin contact
21,729 posts in 4,543 threads, 1,543 registered users;
online 13 (0 registered, 13 guests [including 4 identified bots]).
Forum time: Saturday 23:31 CEST (Europe/Vienna)

If you want to converse with me,
define your terms.    Voltaire

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