in vivo data before tweaking in vitro [Dissolution / BCS / IVIVC]

posted by Helmut Homepage – Vienna, Austria, 2017-06-24 21:30 (2786 d 22:14 ago) – Posting: # 17501
Views: 8,226

Hi Kiran,

a generic product must demonstrate BE in the rate (Cmax) and extent of absorption (AUC), right?
If your dissolution method is not predictive (you can’t tell before you have in vivo data!) any difference might – or might not – be relevant.
Run a small pilot study to get an idea. IMHO, it is a waste of time to first tweak the dissolution which possibly was overdiscriminatory.

Dif-tor heh smusma 🖖🏼 Довге життя Україна! [image]
Helmut Schütz
[image]

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

Complete thread:

UA Flag
Activity
 Admin contact
23,376 posts in 4,912 threads, 1,662 registered users;
264 visitors (0 registered, 264 guests [including 21 identified bots]).
Forum time: 18:45 CET (Europe/Vienna)

There are sadistic scientists who hurry to hunt down errors
instead of establishing the truth.    Marie Curie

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