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jag009 ★★★ NJ, 2015-10-19 22:32 (3902 d 13:43 ago) Posting: # 15572 Views: 8,693 |
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Hi guys, Question. Has anyone conducted BE (not PD) studies with inhalants? If so, in general how are the intra-subject CVs? No worse than oral BE studies? Thanks John |
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ElMaestro ★★★ Denmark, 2015-10-19 22:43 (3902 d 13:33 ago) @ jag009 Posting: # 15573 Views: 6,785 |
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Hi Jag, rule of thumb: The CV's will be between 18%-32%, but only if you use good CROs. Inhaler training is important, but nowadays most companies do it quite well. Importantly: Don't rely on in vitro data when executing a pivotal trial and pick only the best CROs. — Pass or fail! ElMaestro |
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BE-proff ● 2015-10-23 12:32 (3898 d 23:43 ago) @ jag009 Posting: # 15577 Views: 6,581 |
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Hi jag, If it is not a secret what inhalants you are going to investigate in BE studies?  IMHO most of them work locally (esp. for BA and COPD) so it is worth doing therapeutic equivalence study. Or you medications are for another diseases?  |
Ing. Helmut Schütz