Truncated AUC for long half-life drugs [Design Issues]

posted by Ohlbe – France, 2009-07-06 00:33 (6196 d 22:28 ago) – Posting: # 3925
Views: 3,582

Dear Helmut,

❝ Yes, we had a long discussion in Bonn last January what's

❝ a 'long half-life'. Some members of EMEA's EWP/PK-group expressed that

❝ they don't expect any sampling beyond 72 hours for all IR

❝ formulations (irrespective of the half-life). No clear position.


How could they consider that drug A does not qualify as 'long half-life' and ask for 96 hours sampling because some subjects may have more than 20 % extrapolation, and then say that 72 hours are enough for long half-life, because absorption is over anyway ?

❝ Haha, see this tread. :-(


Oh yes, that's the answer :crying:

Regards
Ohlbe

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