BCS II waiver approach [Dissolution / BCS / IVIVC]

posted by yuvaneshwari – India, 2019-01-23 06:09 (605 d 04:34 ago) – Posting: # 19801
Views: 1,979

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:

Activity
 Admin contact
21,068 posts in 4,392 threads, 1,465 registered users;
online 17 (0 registered, 17 guests [including 8 identified bots]).
Forum time: Saturday 11:43 CEST (Europe/Vienna)

The purpose of models is not to fit the data,
but to sharpen the questions.    Samuel Karlin

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