Pentosan Polysulfate Sodium Bioequivalence study [Regulatives / Guidelines]

posted by Maitri – India, 2019-05-31 08:33 (2174 d 03:08 ago) – Posting: # 20307
Views: 3,958

❝ 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:

UA Flag
Activity
 Admin contact
23,424 posts in 4,927 threads, 1,668 registered users;
91 visitors (0 registered, 91 guests [including 49 identified bots]).
Forum time: 11:42 CEST (Europe/Vienna)

No matter what side of the argument you are on,
you always find people on your side
that you wish were on the other.    Thomas Berger

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