Bioequivalence and Bioavailability Forum

Dear all!

❝ Hopefully I will post a little collection the next days.

As promised…

IMHO everybody dealing with NCA and BE-statistics should get the pioneering paper by Sauter et al. (1992)!

Sauter R, Steinijans VW, Diletti E, Böhm E, Schulz H-U. Presentation of results from bioequivalence studies. Int J Clin Pharm Ther Toxicol. 1992; 30(Suppl1): S7–S30.

Method #1 considered a better metric than Method #5 according to simulations:

Tozer TN, Bois FY. Metrics of Absorption; Simulation Approach. In: Blume HH, Midha KK (Eds.), Bio-International 2 - Bioavailability, Bioequivalence and Pharmacokinetic Studies. Stuttgart: medpharm; 1995. p. 51–60.

A nice comparison of Methods #4 and #5 in Chapter 3.7 (Non-Compartmental Analysis); lin-up/log-down trapezoidal recommended variant of Method #1:

Gabrielsson J, Weiner D. Pharmacokinetic an Pharmacodynamic Data Analysis: Concepts and Applications. Stockholm: Swedish Pharmaceutical Press; 3^rd ed. 2000. p. 141–153.

For a dicussion of different methods see also:

Pabst G. Area under the concentration-time curve. In: Cawello W (Ed.), Parameters for Compartment-Free Pharmacokinetics. Aachen: Shaker-Verlag; 2003. p. 65–80.

Method #4 is given in (F5.9), and Method #5 as an alternative in (F5.9a).

Chapter 6 (Presentation of bioequivalence studies) from a recent book:

Hauschke D, Steinijans V, Pigeot I. Bioequivalence Studies in Drug Development. Chichester: John Wiley; 2007. p. 123–155.