Bioequivalence and Bioavailability Forum

Hi Helmut,

❝ So? My drug had a half life of 2–3 hours acc. to the literature.

❝ With the proper estimation I got 4.63 ± 1.07 h (test) and 5.59 ± 1.19 h (reference).

❝ Which half lives were given in your case and which ones did you estimate?

Half-life from literature is around 2 hours. t1/2 from my previous studies were around 2-3 hrs (w BLQ much much higher than my current studies).

❝ ❝ It's an IR product and the drug is very old.

❝

❝ Paracetamol?

Shhhh...

❝ ❝ … while I picked data from more timepoints from both the 1nd phase and the 2nd phase of the elimination phase.

❝

❝ Don’t. Then you are doing sumfink similar to the example in my slide 17. Even if not that extreme, you must not “mix” phases. It might well be that the second phase is not relevant. That’s why Harold Boxenbaum developed the concept of effective half life.

Understood. I was just goofing around to try and see what would happen to R2 if I just selected more timepoints.

Thx
J