Bioequivalence and Bioavailability Forum

Main page Policy/Terms of Use Abbreviations Latest Posts

 Log-in |  Register |  Search

Back to the forum  Query: 2017-09-26 02:17 CEST (UTC+2h)
 

syrup hybrid application [Regulatives / Guidelines]

posted by Aga - US, 2017-09-06 13:52  - Posting: # 17784
Views: 415

Hi,
How could we proof equivalence for syrups, to authorise strength 5 mg/ml when only lower strength of reference product is available (2 mg/ml)? BEQ? In vitro?
The substance is present for more than half of a century on the market and efficacy for tablet (10 and 25 mg) and syrup lower strength (2 mg/ml) is documented in the literature.
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;
28 users online (0 registered, 28 guests).

It has yet to be proven
that intelligence has any survival value.    Arthur C. Clarke

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