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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Autors principals:	Eunjung Song, Woojoo Lee, Bo-Hyung Kim
Format:	Artigo
Idioma:	Inglês
Publicat:	MDPI AG 2021-10-01
Col·lecció:	Pharmaceuticals
Matèries:	highly variable drugs reference-scaled average bioequivalence pharmacokinetic model
Accés en línia:	https://www.mdpi.com/1424-8247/14/11/1101
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