Bioequivalence and Bioavailability Forum

Dear Helmut,

Situation:
1st period was dosed in 1 group and completed in CRO 1
2nd period must now be performed at a different CRO (CRO 2)
2nd period must be performed in 2 groups in CRO 2

Protocol amendment:
Switch in CRO including all tasks
due to the change of dosing in 1 group to 2 groups in period 2 the washout will be different between the two groups.

Does this trigger the evaluation of a group effect, although the groups may only be separated by 1 week?

Is there special statistics we need to consider to address this properly?

Thanks

kind regards,
Silke