such
☆    

2007-09-10 15:01
(6454 d 11:28 ago)

Posting: # 1069
Views: 6,143
 

 exclusion of subject from BE study [Outliers]

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Hi everybody,

Please tell me if we can exclude a subject from statistical analysis if we get concentrations above LLOQ at only two timepoints for a period? Is it stated in any guideline? :confused:
 
Ohlbe
★★★

France,
2007-09-10 15:56
(6454 d 10:34 ago)

@ such
Posting: # 1070
Views: 4,843
 

 No measurable concentration in one period

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Dear Such,

Did you get this problem after administration of the test product ? Or with the reference product ? Or both ?

If you have this after administration of the test, and administration was performed correctly (and with a mouth check), you are in trouble...

Regards
Ohlbe
 
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