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Back to the forum  Query: 2017-11-23 19:14 CET (UTC+1h)

Enlighten me please [Regulatives / Guidelines]

posted by ElMaestro - Denmark, 2017-09-06 22:52  - Posting: # 17788
Views: 681

Hi Jag,

» I don't get it. The message has always been (or almost always been) to show BE for parent if it can be accurately quantified since it is the one that gets absorbed. Someone was :party: when the document was written?

I agree this is unusual. I don't know if they were partying too hard when they wrote this guideline but I can easily imagine there is a compromise of sorts involved here; perhaps someone from another FDA office (DBRUP?) wasn't convinced or was inexperienced with BE and used intuition instead of reason? Sometimes these guidelines, even though they are issued by OGD, involve a ton of inter-division compromises. I am sure that unless you find a really good reason buried in the material on the originator available via FOI the reason is going to be very hard to identify. :-|

We all have to be sheep in this situation, I guess.:-):-)

I could be wrong, but…

Best regards,

No, I still don't believe much in the usefulness of IVIVCs for OIPs when it comes to picking candidate formulations for the next trial. This is not the same as saying I don't believe in IVIVCs.

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