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Model-Based Approach for Designing an Efficient Bioequivalence Study for Highly Variable Drugs
The statistical procedures as outlined by the European Medicines Agency (EMA) and United States Food and Drug Administration (FDA) guidelines for bioequivalence testing of highly variable drugs (HVDs) are complex. Additionally, the sample size is affected by clinical study designs or practical real-...
| Autores principales: | , , |
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| Formato: | Online Artículo Texto |
| Lenguaje: | English |
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MDPI
2021
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| Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8624447/ https://www.ncbi.nlm.nih.gov/pubmed/34832883 http://dx.doi.org/10.3390/ph14111101 |