Bioequivalence and Bioavailability Forum

Main page Policy/Terms of Use Abbreviations Latest Posts

 Log-in |  Register |  Search

Back to the forum  Query: 2018-02-21 15:45 CET (UTC+1h)
 

syrup hybrid application [Regulatives / Guidelines]

posted by Aga - US, 2017-09-07 13:52  - Posting: # 17791
Views: 1,209

Dear ElMaestro,

Thank you very much for your response. Yes, EU submission is considered and the aim of the project is to make posology more practical, as with the low strength the adult is consuming the whole package in less than 2 days.
If we would go 10.3 - how we should prove equivalence with this tricky syrup? Bioequivalence - because the product is not pharmaceutically equivalent? or can we somehow prove pharmaceutical equivalence with double dose vs single dose? Is it possible?

best regards,
Aga

Complete thread:

Back to the forum Activity
 Mix view
Bioequivalence and Bioavailability Forum | Admin contact
17,924 Posts in 3,815 Threads, 1,119 registered users;
37 users online (1 registered, 36 guests).

For every expert there is an equal and opposite expert.    Arthur C. Clarke

The BIOEQUIVALENCE / BIOAVAILABILITY FORUM is hosted by
BEBAC Ing. Helmut Schütz
XHTML/CSS RSS Feed