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...

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Vydáno v:	Journal of drug delivery science and technology Ročník 108; s. 106888
Hlavní autoři:	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
Médium:	Journal Article
Jazyk:	angličtina
Vydáno:	Elsevier B.V 01.06.2025
Témata:	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
On-line přístup:	Získat plný text
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