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RegisterTruncated AUC for long half-life drugs [Design Issues]
Helmut et al - Greetings from Ireland where it is pissing rain as usual (and also very green)!
The latest draft guidelines seem to suggest that it should no longer be necessary to measure out beyond 72 hours in BE studies where the drug has a long half-life (though I note that "long half-life" is not defined). Do you know whether or not practice has changed yet, or are drug companies and CROs still sampling out beyond 72 hours "just to be safe"?
Kind regards
Andrew Leary
The latest draft guidelines seem to suggest that it should no longer be necessary to measure out beyond 72 hours in BE studies where the drug has a long half-life (though I note that "long half-life" is not defined). Do you know whether or not practice has changed yet, or are drug companies and CROs still sampling out beyond 72 hours "just to be safe"?
Kind regards
Andrew Leary
Complete thread:
- Truncated AUC for long half-life drugsDr Andrew Leary 2009-07-01 16:57
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- 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 drugs Ohlbe 2009-07-05 22:33
- Truncated AUC for long half-life drugs Helmut 2009-07-01 17:49
Ing. Helmut Schütz