Replicates Number for Drug Stability Testing during Bioanalytical Method Validation—An Experimental and Retrospective Approach

Background: The stability of a drug or metabolites in biological matrices is an essential part of bioanalytical method validation, but the justification of its sample size (replicates number) is insufficient. The international guidelines differ in recommended sample size to study stability from no r...

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Detalles Bibliográficos
Autores principales: Gniazdowska, Elżbieta, Goch, Wojciech, Giebułtowicz, Joanna, Rudzki, Piotr J.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2022
Materias:
Article
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8779260/
https://www.ncbi.nlm.nih.gov/pubmed/35056772
http://dx.doi.org/10.3390/molecules27020457

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8779260/
https://www.ncbi.nlm.nih.gov/pubmed/35056772
http://dx.doi.org/10.3390/molecules27020457

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