Reversed procedure? [Dissolution / BCS / IVIVC]

posted by Helmut Homepage – Vienna, Austria, 2018-07-03 15:33 (1252 d 01:09 ago) – Posting: # 19012
Views: 30,275

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 🖖
Helmut Schütz
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