Specificity requirement for FDC and concomitant medication [Bioanalytics]

posted by Ohlbe – France, 2023-07-10 11:43 (314 d 00:43 ago) – Posting: # 23667
Views: 1,221

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.


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