Log in
RegisterNon-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.
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.
Complete thread:
- Non-aqueous solutionsThe Outlaw Torn 2020-02-24 08:58 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
Ing. Helmut Schütz