Down with Big Brother [NCA / SHAM]

posted by Helmut Homepage – Vienna, Austria, 2019-02-04 14:43  – Posting: # 19860
Views: 2,985

Hi Nastia,

» Through "atavism" I meant something like a tail in human body - smthg that should be dissapeared while evolution.

OK, but atavism works the other way ’round. A baby born with a tail. An anachronism would be using a sliding rule instead of pocket calculator.

» May I clarify once more: for non-comparative PK trials of IR do we need only classical global Cmin?

Not sure what you mean by “non-comparative PK trial of IR”. For IR you don’t need it at all (Cmin,ss was suggested in the draft IR-GL but didn’t make it to the final version). In the comments we find the nice apples-and-oranges sentence:

“By Cmin,ss we mean the concentration at the end of the dosage interval, i.e. Ctrough.”

Given. Common understanding: Cmin,ss = Ctrough, which is  Cτ,ss in case of a lag-time. Even without a lag-time due to variability Cmin,ss can be observed at the beginning or the end of the dosing interval. Sigh.

In a hybrid application (no MR on the market; comparison to IR or even a solution) I would say Css,min. BTW, currently I’m dealing with a hybrid for Canada. It’s a biphasic product with a lag-time. After some to-and-fro: Both Css,min and Cτ,ss. Oh dear…

» Аnd for MR Ctrough (as it is written in the article)?

Yep – if the two Lászlós meant Cτ,ss. ;-)

Cheers,
Helmut Schütz
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