Bioequivalence and Bioavailability Forum • in vivo data before tweaking in vitro

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

posted by Helmut – Vienna, Austria, 2017-06-24 21:30 (2496 d 06:31 ago) – Posting: # 17501
Views: 7,629

Hi Kiran,

a generic product must demonstrate BE in the rate (C_max) 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!
Helmut Schütz

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

Complete thread:

Dissolution profie matching Kiran 2017-06-24 18:25
- in vivo data before tweaking in vitroHelmut 2017-06-24 19:30
  - in vivo data before tweaking in vitro Kiran 2017-06-24 20:19
    - locally acting / diss. similarity mandatory Helmut 2017-06-25 12:48
      - locally acting / diss. similarity mandatory Kiran 2017-06-25 16:40
- Dissolution profie matching ElMaestro 2017-06-25 20:21
  - Dissolution profie matching Kiran 2017-06-26 05:11