Reversed procedure? [Dissolution / BCS / IVIVC]

posted by Helmut Homepage – Vienna, Austria, 2018-07-03 17:33 (2208 d 05:36 ago) – Posting: # 19012
Views: 32,421

Hi Outlaw Torn,

I agree. The original ideas behind BCS-based biowaiver were:
  1. BE-studies of solutions are not required.
  2. If an oral formulation behaves like a solution, BE-studies could be waived.
#1 was applied for ages. Only recently certain conditions about excipients were added.
Which conditions have to be applied for #2 depends on the BCS class, excipients, no NTID, :blahblah:

I see no scientific reason why the procedure should not be reversed (test = solution, reference = IR).

❝ Science and regulations really are strange bedfellows.


Yep.

❝ Maybe Helmet can bring this subject up at the BioBridges conference during the discussion on ICH M9 (hint, hint, nudge, nudge). ;-)


Helmut Helmet (watch [image] this).
Henrike Potthast worked on ICH M9. She is always open for discussions. Why don’t you go there and ask her yourself? At trip to Prague is way cheaper than an in vivo study. ;-)

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
23,112 posts in 4,858 threads, 1,644 registered users;
69 visitors (0 registered, 69 guests [including 10 identified bots]).
Forum time: 23:10 CEST (Europe/Vienna)

Skill is a function of chance.
It’s an intuitive best-use of chance situations.    Philip K. Dick

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