Predictive Potential of C<sub>max</sub> Bioequivalence in Pilot Bioavailability/Bioequivalence Studies, through the Alternative ƒ<sub>2</sub> Similarity Factor Method
Pilot bioavailability/bioequivalence (BA/BE) studies are downsized trials that can be conducted prior to the definitive pivotal trial. In these trials, 12 to 18 subjects are usually enrolled, although, in principle, a sample size is not formally calculated. In a previous work, authors recommended th...
Main Authors: | , , , |
---|---|
Format: | Article |
Language: | English |
Published: |
MDPI AG
2023-10-01
|
Series: | Pharmaceutics |
Subjects: | |
Online Access: | https://www.mdpi.com/1999-4923/15/10/2498 |