Bioequivalence and Bioavailability Forum

jag009 ★★★ NJ, 2015-11-16 17:28 (3878 d 09:30 ago) Posting: # 15641 Views: 4,237	FDA BE: Truncate AUC for long half-life drug [Regulatives / Guidelines] Post reply
	Hi all, Truncate AUC can be used for a drug with long half-life. Question, is there a limitation as to how long? What if the molecule of interest has a half-life of 15-20 days? Still applicable? Thanks John

d_labes ★★★ Berlin, Germany, 2015-11-16 17:51 (3878 d 09:06 ago) @ jag009 Posting: # 15642 Views: 3,276	FDA BE: Truncate AUC for long half-life drug Post reply
	Dear John! Forgotten your own question on the same subject ? And Helmut's answer? Here is it. Ok it's from 2012. But AFAIK there is no new information on this subject meanwhile. Beside the fact that for highly variable drugs truncation shouldn't be used. See f.i. this thread. — Regards, Detlew

FDA BE: Truncate AUC for long half-life drug [Regulatives / Guidelines]