HIGHLIGHTS
- who: Kris Warman from the BEBACNeubaugasse, Austria have published the article: Critical Remarks on Reference-Scaled Average Bioequivalence, in the Journal: (JOURNAL)
SUMMARY
Comparative bioavailability studies are used in the regulatory approval process of generics, supporting formulation changes, developing line extensions to approved products, and for testing of drug-drug interactions or food effects. In the next sections the concept of average bioequivalence (ABE), scaled average bioequivalence (SABE), average bioequivalence with expanding limits (ABEL), and reference-scaled average bioequivalence (RSABE) are introduced, where ABEL and RSABE approaches require replicated crossover designs (i.e . . .
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