Specificity requirement for FDC and concomitant medication [Bioanalytics]

posted by Ohlbe – France, 2023-07-10 11:43 (658 d 08:15 ago) – Posting: # 23667
Views: 2,379

Dear Karthik,

According to the ICH M10 guideline, section 3.2.8:

For fixed dose combination products and specifically labelled drug regimens, the freeze-thaw, bench-top and long-term stability tests of an analyte in matrix should be conducted with the matrix spiked with all of the dosed compounds.

I would consider that both cases you describe fall under this category. Meaning that even if you already have stability data for each analyte separately, you would still need to repeat the stability evaluation with the combined products.

I would also consider that in both cases described, you should perform a specificity experiment, considering the provisions of section 3.2.2.

In your case 2: if you are not measuring the concomitant medication, I would not consider it necessary for the QC samples to contain that analyte, if specificity and stability have been demonstrated as above.

Regards
Ohlbe

Complete thread:

UA Flag
Activity
 Admin contact
23,424 posts in 4,927 threads, 1,673 registered users;
94 visitors (0 registered, 94 guests [including 1 identified bots]).
Forum time: 19:58 CEST (Europe/Vienna)

There are two possible outcomes: if the result confirms the
hypothesis, then you’ve made a measurement. If the result is
contrary to the hypothesis, then you’ve made a discovery.    Enrico Fermi

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