Bioequivalence and Bioavailability Forum

Dear Santosh!

❝ when t_el is equal or more than 24 hours, then we will go for

❝ Truncated, but what is limit for t_el for Truncated design? when

❝ we go for parallel design (what is limit for t_el for parallel

❝ design)?

There's no agreement, but Canada suggested 24 hours in 2005. The European Draft Guideline from 2008 suggested no sampling beyond 72 hours for all IR formulations irrespective of the half-life.

❝ when we go for parallel design (what is limit for t_el for

❝ parallel design)?

It's up to you. ± points you should consider:
- Power (for a given sample size) in a parallel design is lower than in a cross-over
+ Less chance for drop-outs in a long wash-out