syrup hybrid application [Regulatives / Guidelines]

posted by Aga – US, 2017-09-06 15:52 (2395 d 16:39 ago) – Posting: # 17784
Views: 5,811

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:

UA Flag
Activity
 Admin contact
22,957 posts in 4,819 threads, 1,636 registered users;
102 visitors (0 registered, 102 guests [including 7 identified bots]).
Forum time: 07:31 CET (Europe/Vienna)

With four parameters I can fit an elephant,
and with five I can make him wiggle his trunk.    John von Neumann

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5