Homework [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2018-05-23 19:36 (1344 d 02:29 ago) – Posting: # 18806
Views: 2,311

Hi Biostats,

see also this post #3, specifically:

If you are interested in regulatory requirements, please consult the guidance collection first.
If you can’t find what you’re looking for, then start a new thread and hopefully others will find that thread useful in the future. If it is clear that you have done basic back­ground research, you are far more likely to get an informative response.
It seems that some of our members take this advice not seriously enough. One hint is that the average number of replies in the category Regulatives / Guidelines is less than three. In other words, many posts are essentially of the type “Where can I find regulation X?” and the reply “There!”… Please do your homework first.

» […] in what situation potency correction BE results are required?

Guidance, Section 2.1:

The measured drug content of the lots of the test and reference products, used in the study (expressed as percent of the label claim) should be within 5% of each other. Certificates of analysis documenting potency should be generated within 6 months prior to the start of the study.
In exceptional cases where a reference batch with a measured drug content differing less than 5% from the test product cannot be found, potency correction may be accepted. If potency correction is to be used, this intention should be pre-specified in the protocol and justified. The results from the potency assay of the test and reference products should be submitted. In such cases, the applicable bioequivalence standards should be met on both potency-corrected and uncorrected data.

» How to calculate potency correction BE results for Canada submission?
» Is there any formula or reference literature?

Are you serious?

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Helmut Schütz

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