Investigating Rates of Food and Drug Administration Approvals and Guidances in Drug Development: A Structural Breakpoint/Cointegration Timeseries Analysis

Background The number of original and supplemental ANDAs, BLAs, NDAs, and Biosimilars FDA drug/biologic approvals (Approvals) has risen dramatically in the recent years, incidentally, so has the number of issued FDA guidances (Guidances). It is hypothesized that if the structures of the two timeseri...

Ausführliche Beschreibung

Bibliographische Detailangaben

Veröffentlicht in:	Therapeutic innovation & regulatory science 2020-09, Vol.54 (5), p.1056-1067
1. Verfasser:	Daizadeh, Iraj
Format:	Artikel
Sprache:	eng
Schlagworte:	Drug development Drug Safety and Pharmacovigilance Integration Investigations Life Sciences & Biomedicine Medical Informatics Medicine Original Research Pharmacology & Pharmacy Pharmacotherapy Pharmacy Regulatory agencies Science & Technology Seasonal variations Statistical analysis
Online-Zugang:	Volltext
Tags:	Tag hinzufügen Keine Tags, Fügen Sie den ersten Tag hinzu!