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RegisterThe “backdoor” [Bioanalytics]
posted by Helmut 
– Vienna, Austria, 2017-12-16 14:23 (2315 d 13:51 ago) – Posting: # 18065
Views: 2,640
Hi ElMaestro,
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”:
❝ 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. 🚮
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Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
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