Posting: # 18064
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.
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Posting: # 18065
» what is the current regulatory sentiment towards the need for chiral assays?
Duno. Agree with your other statements. See also this post. At a conference in 2014 another regulator told me that this paragraph is a kind of “backdoor”:
If we don’t like [sic!] the study and find no other reason to reject it, we can use the backdoor…Note also that all product-specific guidances published so far don’t recommend a chiral assay.
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