Add-on Studies / Sequential Design [Design Issues]
I have some questions regarding add-on studies /sequential design.
- Are these acceptable in bioequivalence studies if specified a priori in the protocol? Would you know if US FDA, EMEA, Canada, ASEAN accept such design?
- When an add-on study is conducted (and combined with the original study), what would be the statistical method of analysis?
- Can we still apply the 90% Confidence Interval criteria for bioequivalence or would it have to be more restrictive i.e. 95% CI?
- Could the first study be discarded if the second study passed the 90% CI BE criteria on its own?
- More importantly, what are its pros and cons with regards to consumer protection or risk.
- Add-on Studies / Sequential Designjoyjac 2006-07-19 05:10