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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...
| Autores principales: | , , , |
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| Formato: | Online Artículo Texto |
| Lenguaje: | English |
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MDPI
2023
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| 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 |