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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Main Authors: Jan Muselík (Author), Alena Komersová (Author), Kateřina Kubová (Author), Kevin Matzick (Author), Barbora Skalická (Author)
Format: Book
Published: MDPI AG, 2021-10-01T00:00:00Z.
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