BE and gender [General Sta­tis­tics]

posted by AngusMcLean – USA, 2013-06-15 17:10 (4747 d 14:09 ago) – Posting: # 10801
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Dr._Dan: Thank you for directing me towards this interesting discussion. It appears to me that the trend of the results of the two studies indicate to me that exposure of the drug in males is higher than females for both studies. It just so happens that in the second study the difference was less pronounced. No; it is not a statistical artifact. The formulations are different.
I am thinking that we have a modified release formulation here and the rate of absorption of the drug is different between the two formulations (test and Reference). The test formulation is slower absorbing?
Could it be that the difference in genders is due to the more pronounced metabolism of the drug by females relative to males?

Are you allowed to say if the drug is highly metabolized?

Angus

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