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Preclinical good laboratory practice-compliant safety study to evaluate biodistribution and tumorigenicity of a cartilage advanced therapy medicinal product (ATMP)Zscharnack, Matthias, Krause, Christoph, Aust, Gabriela, Thümmler, Christian, Peinemann , Frank, Keller, Thomas, Smink, Jeske J., Holland, Heidrun, Somerson, Jeremy S., Knauer, Jens, Schulz, Ronny M., Lehmann, Jörg 27 July 2015 (has links) (PDF)
Background: The clinical development of advanced therapy medicinal products (ATMPs), a new class of drugs, requires initial safety studies that deviate from standard non-clinical safety protocols. The study provides a strategy to address the safety aspects of biodistribution and
tumorigenicity of ATMPs under good laboratory practice (GLP) conditions avoiding cell product manipulation. Moreover, the strategy was applied on a human ATMP for cartilage repair.
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Preclinical good laboratory practice-compliant safety study to evaluate biodistribution and tumorigenicity of a cartilage advanced therapy medicinal product (ATMP)Zscharnack, Matthias, Krause, Christoph, Aust, Gabriela, Thümmler, Christian, Peinemann, Frank, Keller, Thomas, Smink, Jeske J., Holland, Heidrun, Somerson, Jeremy S., Knauer, Jens, Schulz, Ronny M., Lehmann, Jörg January 2015 (has links)
Background: The clinical development of advanced therapy medicinal products (ATMPs), a new class of drugs, requires initial safety studies that deviate from standard non-clinical safety protocols. The study provides a strategy to address the safety aspects of biodistribution and
tumorigenicity of ATMPs under good laboratory practice (GLP) conditions avoiding cell product manipulation. Moreover, the strategy was applied on a human ATMP for cartilage repair.
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