Class I BCS based biowaiver with different amounts of API between T and R [Dissolution / BCS / IVIVC]

posted by joosefupas – Italy, 2018-11-08 11:00  – Posting: # 19548
Views: 1,338

Hello everyone,

I have already googled around the web but couldn't find any answers thus I'll see if anyone can help here!

ICH M9 draft guidance states that “BCS-based biowaivers are applicable to drug products where the drug substance(s) (thus APIs) in test and reference products are identical (e.g. same salt, ester, isomer or mixture of isomers from that in the reference product).

My question now is, what about different API doses/amount between test and reference though?
More specifically our test product contains the exact double amount of APIs (both BCS Class I drugs) of the reference product (1000/130mg of paracetamol/caffeine TEST vs 500/65mg REFERENCE).

Given the API amount difference between T and R do you think a BCS based biowaiver application would still be applicable?

Thanks a lot in advance for the great support

Joosé

Complete thread:

Activity
 Admin contact
20,144 posts in 4,248 threads, 1,385 registered users;
online 15 (0 registered, 15 guests [including 3 identified bots]).
Forum time (Europe/Vienna): 01:48 CET

A little Learning is a dang’rous Thing;
Drink deep, or taste not the Pierian Spring:
There shallow Draughts intoxicate the Brain,
And drinking largely sobers us again.    Alexander Pope

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