Bioequivalence and Bioavailability Forum

Hi Nlpati,

❝ If we have conducted fed and fasting study in one site and the sponsor wants to continue the study with remaining IPs in another site with the same test and reference…

I don’t understand. The study is completed and the sponsor wants to increase the sample size – because the study failed?

• If the study was already assessed for BE (with 90% CIs), the entire α is already spent. Such an ‘Add-on’ inflates the patient’s risk and fortunately is only acceptable in Japan (rightly went into the statistical waste-can in all other jurisdictions).
  
• Even if you post hoc try to transform the study into a Two-Stage design, I have some doubts whether this is a statistically valid approach.

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