The “backdoor” [Bioanalytics]

posted by Helmut Homepage – Vienna, Austria, 2017-12-16 12:23 (1136 d 23:21 ago) – Posting: # 18065
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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.

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Helmut Schütz
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