Adaptation of the quality by design concept in early pharmaceutical development of an intranasal nanosized formulation

Article ID	Journal	Published Year	Pages	File Type
5818724	International Journal of Pharmaceutics	2015	33 Pages	PDF

Keywords

Cmax QTPP CPP PVP TPP API FDA CQA EMA QbD tmax European Medicines agency Nasal administration Risk assessment ISO maximum plasma concentration International Organization for Standardization Food and Drug Administration REF target product profile quality target product profile ICH Active Pharmaceutical Ingredient Reference sample Sodium hyaluronate Critical quality attribute critical process parameter polyethyleneglycol polyvinylpyrrolidone PEG International Conference on Harmonization Quality by design

Related Topics

Health Sciences Pharmacology, Toxicology and Pharmaceutical Science Pharmaceutical Science

Adaptation of the quality by design concept in early pharmaceutical development of an intranasal nanosized formulation

Authors

Edina Pallagi, Rita Ambrus, Piroska Szabó-Révész, Ildikó Csóka,