Truncated AUC for long half-life drugs [Design Issues]
Dear Helmut,
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 ?
Oh yes, that's the answer
Regards
Ohlbe
❝ 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

Regards
Ohlbe
Complete thread:
- Truncated AUC for long half-life drugs Dr Andrew Leary 2009-07-01 16:57
- Truncated AUC for long half-life drugs Helmut 2009-07-01 17:49
- Truncated AUC for long half-life drugs Dr Andrew Leary 2009-07-02 13:47
- Truncated AUC for long half-life drugsOhlbe 2009-07-05 22:33
- Truncated AUC for long half-life drugs Helmut 2009-07-01 17:49
