ICH M9 - reverse engineering? [Regulatives / Guidelines]

posted by dshah – India, 2020-09-17 06:46 (69 d 06:18 ago) – Posting: # 21923
Views: 341

Dear Marta,

» Do you have experience with biowaivers and ICH M9 guideline?

Many do have experience.

» When the M9 guidance mentions that we should have a formulation "qualitatively the same and quantitatively similar", especially for BCS class III drugs, how should be the quantitative formulation of the RLD justified? Is literature data enough, or do we need reverse engineering - and in this case, what is the level required (Q2 or Q3)? Only one method for each attribute or orthogonal analysis required?

When we are taking about biowaiver- mainly its for IR solid orals. and thus Q3 doesn't apply like for creams/gels/complex generic products.
Yes, indirectly reverse engineering is required and then CC/meeting with regulatory agency to confirm the similarity for Q1/Q2 could be one of the way.
Regards,
DShah

Complete thread:

Activity
 Admin contact
21,209 posts in 4,426 threads, 1,481 registered users;
online 14 (1 registered, 13 guests [including 7 identified bots]).
Forum time: Wednesday 12:04 CET (Europe/Vienna)

You can’t fix by analysis
what you bungled by design.    Richard J. Light, Judith D. Singer, John B. Willett

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