First update of the International Xenotransplantation Association consensus statement on conditions for undertaking clinical trials of porcine islet products in type 1 diabetes - Chapter 3: Porcine islet product manufacturing and release testing criteria

In the 2009 IXA consensus, the requirements for the quality and control of manufacturing of porcine islet products were based on the U.S. regulatory framework where the porcine islet products fall within the definition of somatic cell therapy under the statutory authority of the U.S. Food and Drug A...

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Veröffentlicht in:	Xenotransplantation (Københaven) 2016-01, Vol.23 (1), p.38-45
Hauptverfasser:	Rayat, Gina R., Gazda, Lawrence S., Hawthorne, Wayne J., Hering, Bernhard J., Hosking, Peter, Matsumoto, Shinichi, Rajotte, Ray V.
Format:	Artikel
Sprache:	eng
Schlagworte:	Animals Clinical Trials as Topic Diabetes Mellitus, Type 1 - surgery good manufacturing practices Humans Informed Consent - legislation & jurisprudence Islets of Langerhans Transplantation - legislation & jurisprudence Islets of Langerhans Transplantation - methods Patient Selection porcine islets of langerhans Quality Control Swine Transplantation, Heterologous - legislation & jurisprudence type 1 diabetes xenotransplantation
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