Bioequivalence and Bioavailability Forum

Dear Mustafa!

❝ […] from regulatory point of view.

❝

❝ scientifically, would it be acceptable to not analyze all study samples from a in a single run (i.e multiple runs) as long as the bioanalytical method has completely been validated and documented acceptable inter-assay variability?.

❝ is there any justification behind the acceptance of single / multiple run(s) analysis results?

Regulatory or scientific POV?.

❝ is there any references/guidelines that i can refer to regarding this matter?

See EMA’s GL (2011) Section 5.1. I would go with a single batch whenever possible. Even if you have low inter-batch variability, you might see a certain shift within the plasma profiles. If samples are analyzed in a cross-over manner, AUC and C_max should not be affected, but estimating the elimination might give you headaches.