BCS II waiver approach [Dissolution / BCS / IVIVC]

posted by yuvaneshwari – India, 2019-01-23 07:09 (2356 d 04:04 ago) – Posting: # 19801
Views: 4,584

Dear All,

Drug compound is BCS-II [dosage form is solution filled in capsule], and objective is to formulate with Q1 & Q2 sameness to that of Reference. Since API is in solution state filled in capsule, its solubility/bioavailability is improved tremendously.

In the above scenario, can we consider for BCS based waiver approach ?

Complete thread:

UA Flag
Activity
 Admin contact
23,427 posts in 4,929 threads, 1,675 registered users;
46 visitors (0 registered, 46 guests [including 25 identified bots]).
Forum time: 12:13 CEST (Europe/Vienna)

Many people tend to look at programming styles and languages like religions:
if you belong to one, you cannot belong to others.
But this analogy is another fallacy.    Niklaus Wirth

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