Diving into Batch-to-Batch Variability of Topical Products-a Regulatory Bottleneck

Purpose Following the recent European Medicine Agency (EMA) draft guideline on quality and equivalence of topical products, a modular framework for bioequivalence assessment is proposed, wherein the qualitative, quantitative, microstructure and product performance sameness is demanded to support gen...

Ausführliche Beschreibung

Bibliographische Detailangaben

Veröffentlicht in:	Pharmaceutical research 2020-11, Vol.37 (11), p.218-218, Article 218
Hauptverfasser:	Miranda, Margarida, Cova, Tânia, Augusto, Cátia, Pais, Alberto A. C. C., Cardoso, Catarina, Vitorino, Carla
Format:	Artikel
Sprache:	eng
Schlagworte:	Biochemistry Biomedical and Life Sciences Biomedical Engineering and Bioengineering Biomedicine Generic drugs Medical Law Multivariate analysis Pharmacology/Toxicology Pharmacy Research Paper Rheology Statistical analysis
Online-Zugang:	Volltext
Tags:	Tag hinzufügen Keine Tags, Fügen Sie den ersten Tag hinzu!