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What's the current situation regarding chiral assays? [Bioanalytics]

posted by ElMaestro - Denmark, 2017-12-16 12:31  - Posting: # 18064
Views: 858

Hi all,

what is the current regulatory sentiment towards the need for chiral assays?

My impression is, given the EU guideline wording in 4.1.5 and the current practice that I have seen that regulators are not really enforcing the guideline the way it is written but occasionally they just happen to be.
I cannot see a pattern in the practice. If someone asks me when a chiral assay is truly necessary (guideline wording apart) then I will have to draw a blank.

Anyone out there able to describe how the guideline wording translates into assessor practice in plain words?

Many thanks and have a good day.

I could be wrong, but…


Best regards,
ElMaestro

- Bootstrapping for dissolution data is a relatively new hobby of mine.

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