ElMaestro
★★★

Denmark,
2017-12-16 12:31
(1131 d 02:01 ago)

Posting: # 18064
Views: 2,511
 

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

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.

Pass or fail!
ElMaestro
Helmut
★★★
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Vienna, Austria,
2017-12-16 13:23
(1131 d 01:09 ago)

@ ElMaestro
Posting: # 18065
Views: 2,140
 

 The “backdoor”

Hi ElMaestro,

» 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 “loophole”:

“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.

Dif-tor heh smusma 🖖
Helmut Schütz
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