A pharmaceutical industry survey results on the cycle time, drivers and enablers, for key deliverables in the early phase of drug product development from dose limiting toxicity to first subject first dose: The survey conducted by the IQ cycle time benchmarking working group

This paper presents a comprehensive benchmarking analysis of cycle times from Dose Limiting Toxicity (DLT) to First Subject First Dose (FSFD) within the pharmaceutical and biopharmaceutical industry. Conducted by the IQ Consortium Early Phase Cycle Time Benchmarking Working Group (ePCTB WG) under th...

Ausführliche Beschreibung

Bibliographische Detailangaben

Veröffentlicht in:	Journal of drug delivery science and technology Jg. 108; S. 106888
Hauptverfasser:	Campbell, Gossett A., Barrett, Stephanie E., Thakral, Seema, Lowinger, Michael, Faassen, Fried, Vander Kamp, Kirk A., Wagner, Daniel, Bargmann-Leyder, Nathalie, Badawy, Sherif, Gaebele, Tracy, Snyder, Phillip
Format:	Journal Article
Sprache:	Englisch
Veröffentlicht:	Elsevier B.V 01.06.2025
Schlagworte:	Acceleration And first subject first dose Benchmarking Cycle time Dose limiting toxicity Drug product development Early phase And first subject first dose Early phase Benchmarking Dose limiting toxicity Drug product development Acceleration Cycle time
ISSN:	1773-2247
Online-Zugang:	Volltext
Tags:	Tag hinzufügen Keine Tags, Fügen Sie den ersten Tag hinzu!