Predictive Potential of C<sub>max</sub> Bioequivalence in Pilot Bioavailability/Bioequivalence Studies, through the Alternative ƒ<sub>2</sub> Similarity Factor Method

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...

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Detaylı Bibliyografya
Asıl Yazarlar: Sara Carolina Henriques, Paulo Paixão, Luis Almeida, Nuno Elvas Silva
Materyal Türü: Makale
Dil:English
Baskı/Yayın Bilgisi: MDPI AG 2023-10-01
Seri Bilgileri:Pharmaceutics
Konular:
bioequivalence
generic medicinal products
pilot studies
ƒ<sub>2</sub> factor
pharmacokinetics
modelling and simulation
Online Erişim:https://www.mdpi.com/1999-4923/15/10/2498

Internet

https://www.mdpi.com/1999-4923/15/10/2498

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