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-...

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Detalles Bibliográficos
Autores principales: Song, Eunjung, Lee, Woojoo, Kim, Bo-Hyung
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2021
Materias:
Article
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

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8624447/
https://www.ncbi.nlm.nih.gov/pubmed/34832883
http://dx.doi.org/10.3390/ph14111101

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