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ElMaestro ★★★ Denmark, 2017-12-16 13:31 (2312 d 20:59 ago) Posting: # 18064 Views: 3,107 |
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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 |
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Helmut ★★★   Vienna, Austria, 2017-12-16 14:23 (2312 d 20:08 ago) @ ElMaestro Posting: # 18065 Views: 2,630 |
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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 🖖🏼 Довге життя Україна! ![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png) Helmut Schütz ![[image]](https://static.bebac.at/img/CC by.png) The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
Ing. Helmut Schütz