Bioequivalence and Bioavailability Forum • No dissolution?

No dissolution? [Regulatives / Guidelines]

posted by Helmut – Vienna, Austria, 2013-10-03 15:01 (4646 d 10:11 ago) – Posting: # 11596
Views: 3,837

Hi Tina!

❝ […] Being a solution, dissolution wasnt done.

Hhm, I don’t know whether regulators would accept that. For an example see

Hu J, Kyad A, Ku V, Zhou P, and N Cauchon
A Comparison of Dissolution Testing on Lipid Soft Gelatin Capsules Using USP Apparatus 2 and Apparatus 4
Diss Technol 12(2), 6–9 (2005)
free online resource

❝ Is there any possibility of applying the biowaiver/bibliograhic route…

A biowaiver is based on an in vitro comparison, which you haven’t done.

❝ …considering the fact the invivo BE is unlikely to be shown (just hypothesis)?

You have no in vitro similarity and hypothesize (!) that you will not have in vivo BE – why do you think you will get an approval?

—
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:

BE study-oily solution vs tablets Tina 2013-10-03 12:45
- No dissolution?Helmut 2013-10-03 13:01
  - No dissolution? Tina 2013-10-03 13:16
    - No “dissolution” of a solution… Helmut 2013-10-03 13:35
      - No “dissolution” of a solution… Tina 2013-10-03 15:10