jag009
★★★

NJ,
2015-10-19 22:32
(3895 d 09:01 ago)

Posting: # 15572
Views: 8,682
 

 BE studies for Inhalants [Power / Sample Size]

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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
 
ElMaestro
★★★

Denmark,
2015-10-19 22:43
(3895 d 08:51 ago)

@ jag009
Posting: # 15573
Views: 6,774
 

 BE studies for Inhalants

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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
 
BE-proff
●    

2015-10-23 12:32
(3891 d 19:01 ago)

@ jag009
Posting: # 15577
Views: 6,573
 

 BE studies for Inhalants

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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? :cool:
 
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