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Predictive Potential of C(max) Bioequivalence in Pilot Bioavailability/Bioequivalence Studies, through the Alternative ƒ(2) 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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Detalles Bibliográficos
Autores principales: Henriques, Sara Carolina, Paixão, Paulo, Almeida, Luis, Silva, Nuno Elvas
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10610255/
https://www.ncbi.nlm.nih.gov/pubmed/37896259
http://dx.doi.org/10.3390/pharmaceutics15102498