Bioequivalence and Bioavailability Forum

Hi Pharma_88,

❝ Would like to have an opinion for a study (3WCO) …

Excuse my ignorance: 3WCO = Worst-case optimal redistribution?

❝ … with two different RLD (US & EMA).

IR or MR? Check the overarching guidelines. Off note: there are no RLDs in Europe.

• IR (both agencies)
  ICH M13A
  
• MR (both agencies fasting and fed)
  FDA: single dose
  EMA: single dose – and likely – multiple dose

Check also whether PSGs for your product are applicable.

❝ As per my knowledge, this will be a T, R1, R2 (3 sequences) study where we need to prove bioequivalence of T/R1 and T/R2. Right?

Correct. Use the ‘Two at a Time’ approach, i.e., exclude the comparator not relevant for the comparisons of interest. Do not use the ‘All at Once’ approach, i.e., a single ANOVA of pooled data.

❝ Furthermore, would also like to know whether a separate Fast and Fed study is required or if there is any other design that can be opted to cover both conditions in a single study with two RLD?

If you need one at all (see above), both is possible. However, with two comparators and both pranial states in a single you would need six periods…