Bioequivalence and Bioavailability Forum

Hi Nee!

❝ The guideline says that 95% upper confidence bound should be less than or equal to zero. Is there any chance that the 95% upper confidence bound will be equal to zero?

Yes, although very, very small.

❝ How many decimal places should we keep for the same?

Good question! I guess most people calculate the CL in full precision and set up their software in such a way that a verbatim statement is printed. At least this is what I do. On the other hand FDA's SAS code for unscaled ABE does not include a rounding statement – which is required according to the 2003 guidance. Since inclusion of the 90% CI requires rounding to two decimal places (i.e., four significant digits if <100% and five significant digits if ≥100%) rounding of the upper 95% CL to five significant digits may be an option. Interested in other opinions.