Add-on Studies / Sequential Design [Design Issues]

posted by joyjac – Philippines, 2006-07-19 07:10 (6097 d 21:16 ago) – Posting: # 179
Views: 10,630

I have some questions regarding add-on studies /sequential design.
  1. 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?
  2. When an add-on study is conducted (and combined with the original study), what would be the statistical method of analysis?
  3. Can we still apply the 90% Confidence Interval criteria for bioequivalence or would it have to be more restrictive i.e. 95% CI?
  4. Could the first study be discarded if the second study passed the 90% CI BE criteria on its own?
  5. More importantly, what are its pros and cons with regards to consumer protection or risk.
Thank you so much for the knowledge sharing.

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