A Critical Overview of FDA and EMA Statistical Methods to Compare In Vitro Drug Dissolution Profiles of Pharmaceutical Products

A Critical Overview of FDA and EMA Statistical Methods to Compare In Vitro Drug Dissolution Profiles of Pharmaceutical Products

A drug dissolution profile is one of the most critical dosage form characteristics with immediate and controlled drug release. Comparing the dissolution profiles of different pharmaceutical products plays a key role before starting the bioequivalence or stability studies. General recommendations for...

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Bibliographic Details
Main Authors: Jan Muselík, Alena Komersová, Kateřina Kubová, Kevin Matzick, Barbora Skalická
Format: Article
Language:English
Published: MDPI AG 2021-10-01
Series:Pharmaceutics
Subjects:
drug dissolution
dissolution profile comparison
EMA and FDA strategy
Online Access:https://www.mdpi.com/1999-4923/13/10/1703

Internet

https://www.mdpi.com/1999-4923/13/10/1703

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