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

• Principais autores: Jan Muselík (Autor), Alena Komersová (Autor), Kateřina Kubová (Autor), Kevin Matzick (Autor), Barbora Skalická (Autor)
• Formato: Livro
• Publicado em: MDPI AG, 2021-10-01T00:00:00Z.
• Assuntos: article
• Acesso em linha: 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...