Pentosan Polysulfate Sodium Bioequivalence study [Regulatives / Guidelines]

posted by Maitri – India, 2019-05-31 08:33 (1791 d 04:01 ago) – Posting: # 20307
Views: 3,029

❝ 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
22,993 posts in 4,828 threads, 1,655 registered users;
128 visitors (0 registered, 128 guests [including 2 identified bots]).
Forum time: 12:34 CEST (Europe/Vienna)

Never never never never use Excel.
Not even for calculation of arithmetic means.    Martin Wolfsegger

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