Specifics of RSABE methodology vary between regulatory agencies, but both the European Medicines Agency (EMA) and the United States Food and Drug Administration (FDA) require that subjects receive the reference drug more than once, e.g., replicated 3-period (RRT/RTR/TRR) or 4-period (RTRT/TRTR) crossover designs, so that the BE analysis accounts for within-subject variability. Reference-scaled average bioequivalence (RSABE) methodology is increasingly used to demonstrate bioequivalence for HVDs/HVDPs. This increases the expense of BE studies, places more study subjects at risk, and ultimately limits the availability of generics. Traditional average bioequivalence (ABE) methodology requires prohibitively large sample sizes when used with highly variable drugs and drug products (HVDs/HVDPs), which are defined as products with intra-subject CV% of the reference greater than 30%. Please register below:Ĭ/certara/onstage/g.php?d=929560162&t=a
S3./Certara-Presentations/2./AAPS_2013_RSABE.zipĪ free webinar is scheduled for December 3rd, at 11EST to demonstrate how to use these templates. These templates are available for download at
Workflow templates to do reference-scaled average bioequivalence (RSABE) have been developed in Phoenix WinNonlin 6.3.
