Fant 9758 publikasjoner. Viser side 131 av 391:
2006
2007
2006
2005
2006
2016
2016
2020
Academic Press
2021
2012
ExSIRA - Experimental study to investigate risk of selected amines (project no. 199874/S60). NILU PP
2011
ExSIRA - Experimental study to investigate risk of selected amines (project no. 199874/S60). NILU PP
2013
2005
2015
2008
2009
2016
Extracellular Vesicles as Next-Generation Diagnostics and Advanced Therapy Medicinal Products
Extracellular vesicles (EVs) hold great promise for clinical application as new diagnostic and therapeutic modalities. This paper describes major GMP-based upstream and downstream manufacturing processes for EV large-scale production, also focusing on post-processing technologies such as surface bioengineering and uploading studies to yield novel EV-based diagnostics and advanced therapy medicinal products. This paper also focuses on the quality, safety, and efficacy issues of the bioengineered EV drug candidates before first-in-human studies. Because clinical trials involving extracellular vesicles are on the global rise, this paper encompasses different clinical studies registered on clinical-trial register platforms, with varying levels of advancement, highlighting the growing interest in EV-related clinical programs. Navigating the regulatory affairs of EVs poses real challenges, and obtaining marketing authorization for EV-based medicines remains complex due to the lack of specific regulatory guidelines for such novel products. This paper discusses the state-of-the-art regulatory knowledge to date on EV-based diagnostics and medicinal products, highlighting further research and global regulatory needs for the safe and reliable implementation of bioengineered EVs as diagnostic and therapeutic tools in clinical settings. Post-marketing pharmacovigilance for EV-based medicinal products is also presented, mainly addressing such topics as risk assessment and risk management.
MDPI
2024
2015
2004
2005
2014