What is meant by data amenable? [Regulatives / Guidelines]

posted by GM – India, 2020-03-16 12:59 (398 d 00:10 ago) – Posting: # 21281
Views: 2,033

Dear all,

As per the ICH Q1E, to estimate the retest period/shelf life of the drug product, we need to perform the statistical analysis; if data is amenable.

Here my question is what is meant by "amenable"?

I have googled for the same information. To check this, we have study three things about the data (e.g., assay results).

a) Magnitude of results
b) Sample size (means number of data points available for the analysis)
c) Variance in the data

Expecting more thoughts on this topic.

Please correct me, if I am wrong.

Best Regards,

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