Proposing some innovative study design features to regulatory agencies (EMA and FDA) in bioequivalence trials : Reference Scaled Average Bioequivalence, and Two-Stage Adaptive Designs 

Molins Lleonart, Eduard (Date of defense: 2021-05-28)

In applications for generic medicinal products the concept of bioequivalence is fundamental. Two medicinal products, i.e. a test and a reference drugs containing the same active substance are considered bioequivalent if ...