Translation of nonclinical to clinical safety findings for 27 biotherapeutics

Human adverse drug reactions (ADRs), and in vivo nonclinical adverse and nonadverse findings, were identified in 27 biotherapeutic programs and placed into organ categories to determine translation. The sensitivity of detecting human ADRs was 30.8% with a positive predictive value (PPV) of 53.3% for...

Ausführliche Beschreibung

Bibliographische Detailangaben

Veröffentlicht in:	Toxicology and applied pharmacology 2024-03, Vol.484, p.116854-116854, Article 116854
Hauptverfasser:	Leach, Michael W., Rana, Payal, Hu, Wenyue, Mittapalli, Rajendar K., Pinkstaff, Jason, Potter, David, Qiu, Xing Min, Ramaiah, Lila, Rohde, Cynthia, Xia, Feng, Khan, K. Nasir
Format:	Artikel
Sprache:	eng
Schlagworte:	Biotherapeutics Immunogenicity Monoclonal Antibodies Predictivity Toxicity Translation
Online-Zugang:	Volltext
Tags:	Tag hinzufügen Keine Tags, Fügen Sie den ersten Tag hinzu!