Bioequivalence and Bioavailability Forum • ICH guideline M10 on BA method validation

PSU
☆

Thailand,
2022-05-03 17:53
(717 d 03:37 ago)

Posting: # 22956
Views: 1,512

ICH guideline M10 on BA method validation [Regulatives / Guidelines]

Dear all experts,

Referring to ICH guideline M10 on BA method validation step2b (line no.413-414, p.11), CC and QCs should be prepared from separate stock solution in order to avoid biased estimations which are not related to the analytical performance of the method.

Can you explain how separate stock solution can avoid biased estimations? and what are the bias estimations that happen regarding this sentence, if we use the same stock solution ?

Thank you so much

PSU

Helmut
★★★

Vienna, Austria,
2022-05-04 16:48
(716 d 04:41 ago)

@ PSU
Posting: # 22960
Views: 1,305

Stock solutions for CCs and QCs

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Hi PSU,

❝ Referring to ICH guideline M10 on BA method validation step2b …

Not new. Similar in the EMA’s guideline of 2011 and the FDA’s guidance of 2018.

❝ Can you explain how separate stock solution can avoid biased estimations?

If you screw up in preparing either the stock solution for calibrators or QCs, likely many batches will fail.

❝ and what are the bias estimations that happen regarding this sentence, if we use the same stock solution ?

If you use different ones, you demonstrate that you can utilize the analytical balance, volumetric flasks, and pipettes properly. :-D

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paulhurleyuk
☆

NE UK,
2022-05-05 13:47
(715 d 07:43 ago)

@ PSU
Posting: # 22962
Views: 1,250

ICH guideline M10 on BA method validation

Post reply

❝ Can you explain how separate stock solution can avoid biased estimations? and what are the bias estimations that happen regarding this sentence, if we use the same stock solution ?

If you just used one weighing, and weighed too little material you would decrease the signal to noise, and potentially make the assay appear less precise/accurate. Conversely weighing too much material would increase signal to noise and make the assay appear more precise. Having two weighing's makes it more likely to spot that issue.

Paul.