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Dr Andrew Leary ★ Ireland, 2009-07-01 18:57 (6202 d 10:08 ago) Posting: # 3920 Views: 4,065 |
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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 |
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Helmut ★★★   Vienna, Austria, 2009-07-01 19:49 (6202 d 09:17 ago) @ Dr Andrew Leary Posting: # 3921 Views: 3,414 |
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Hi Andrew! Once I asked an Irish girl about the weather and she replied with a sweet smile: "Well, it doesn't rain all the time!" ❝ 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). 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. ❝ 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"? Haha, see this tread.  — Dif-tor heh smusma 🖖🏼 Довге життя Україна! ![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png) Helmut Schütz ![[image]](https://static.bebac.at/img/CC by.png) The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
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Dr Andrew Leary ★ Ireland, 2009-07-02 15:47 (6201 d 13:19 ago) @ Helmut Posting: # 3922 Views: 3,287 |
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Still raining here, Helmut! Floods in Dublin but fortunately I'm in Cork.  Many thanks for your answer. The news from the thread you alerted me to sounds depressingly familiar! All the best Andrew |
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Ohlbe ★★★ France, 2009-07-06 00:33 (6198 d 04:32 ago) @ Helmut Posting: # 3925 Views: 3,586 |
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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  Regards Ohlbe |
Ing. Helmut Schütz