Bioequivalence and Bioavailability Forum

Main page Policy/Terms of Use Abbreviations Latest Posts

 Log-in |  Register |  Search

Back to the forum  Query: 2017-09-25 22:29 CEST (UTC+2h)
 

syrup hybrid application [Regulatives / Guidelines]

posted by Aga - US, 2017-09-07 13:52  - Posting: # 17791
Views: 290

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
17,323 Posts in 3,705 Threads, 1,068 registered users;
27 users online (0 registered, 27 guests).

The belief that there is only one truth and
that oneself is in possession of it,
seems to me the deepest root of all
that is evil in the world.    Max Born

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