The Outlaw Torn

2020-02-24 08:58
(366 d 17:39 ago)

Posting: # 21188
Views: 875

 Non-aqueous solutions [Regulatives / Guidelines]

Good morning fellow BEBACers,

EMA BE guidelines for aqueous oral solutions are straight forward. I would assume that BE studies cannot be waived for oral solutions formulated with non-aqueous carriers (medium chain triglycerides) due to the potential for formulation effects even when formulations are Q1Q2 (my assumption is that it would not be possible to confirm Q2 due to the heterogeneity of the triglyceride chain lengths obtained from different providers). Is this your understanding as well?

Are there any other issues to consider, either from a regulatory or clinical standpoint, due to the non-aqueous carrier and seeking registration? For example, if the RLD is not available in this pharmaceutical form, would a article 10(3) be more appropriate than 10(1)? Thank you in advance.
 Admin contact
21,355 posts in 4,458 threads, 1,493 registered users;
online 6 (0 registered, 6 guests [including 3 identified bots]).
Forum time: Thursday 02:37 CET (Europe/Vienna)

The rise of biometry in this 20th century,
like that of geometry in the 3rd century before Christ,
seems to mark out one of the great ages or critical periods
in the advance of the human understanding.    R.A. Fisher

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