Dose based on m² [General Sta­tis­tics]

posted by Dr_Dan  – Germany, 2013-07-17 13:09 (3799 d 04:07 ago) – Posting: # 10993
Views: 8,459

Dear VK
What do you mean by "We did regular calculations"? In a cross-over study BE is based on the intra-individual comparison of test and reference and therefore it is theoretically possible to administer different doses (dose adjusted PK parameters). However, I guess in your case you administered a combination of different strengths (=different products), right?
For example:
70% received 1x100mg
30% received either 1x50mg+1x25mg or 1x100mg+1x25mg
Then indeed only 70% of the subjects could be evaluated since a pure comparison is only possible between your 100 mg product and the originator.
If you had choosen
70% received 4x25mg
30% received either 3x25mg or 5x25mg
Then 100% of the subjects could be evaluated.
Kind regards

Kind regards and have a nice day

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