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

• Main Authors: Jan Muselík (Author), Alena Komersová (Author), Kateřina Kubová (Author), Kevin Matzick (Author), Barbora Skalická (Author)
• 格式: 图书
• 出版: MDPI AG, 2021-10-01T00:00:00Z.
• 主题: article
• 在线阅读: Connect to this object online.

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...