Bioequivalence and Bioavailability Forum

Dear Pavan,

❝ We conducted a study with 2 tests and 1 reference. According to our SOP if R² value is less than 0.75 we need to exclude that subject from the statistical analysis

OK, if your SOP states this cut-off you have to use it. For the meaningfulness of R² as a measure of ‘goodness of fit’ please search the forum. We had rather lengthy discussions on the topic already.

❝ In this 3x3 design for T2 the R² value is showing less than 0.75. We are considering k_el, t_1/2 and AUC_inf for T2 as missing.

What are your considerations? You have to follow your SOP.

❝ Is it applicable to T2 only […]

IMHO yes.

❝ […] or for T1 and R also we need to take them as missing?

Why? For these formulations R² ≥0.075.