10th Anniversary of a Two-Stage Design in Bioequivalence. Why Has it Still Not Been Implemented?

PURPOSE: In 2010 the European Medicines Agency allowed a two-stage design in bioequivalence studies. However, in the public domain there are mainly articles describing the theoretical and statistical base for the application of the two-stage design. One of the reasons seems to be the lack of practic...

Descripción completa

Detalles Bibliográficos
Autores principales: Kaza, Michał, Sokolovskyi, Alexander, Rudzki, Piotr J.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer US 2020
Materias:
Perspective
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7359142/
https://www.ncbi.nlm.nih.gov/pubmed/32661944
http://dx.doi.org/10.1007/s11095-020-02871-3

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7359142/
https://www.ncbi.nlm.nih.gov/pubmed/32661944
http://dx.doi.org/10.1007/s11095-020-02871-3

Ejemplares similares