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RegisterWhat'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.
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
Pass or fail!
ElMaestro
Complete thread:
- What's the current situation regarding chiral assays?ElMaestro 2017-12-16 12:31 [Bioanalytics]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- The “backdoor” Helmut 2017-12-16 13:23
Ing. Helmut Schütz