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Preclinical good laboratory practice-compliant safety study to evaluate biodistribution and tumorigenicity of a cartilage advanced therapy medicinal product (ATMP)
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 AT...
Autores principales: | 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 |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2015
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4445304/ https://www.ncbi.nlm.nih.gov/pubmed/25990108 http://dx.doi.org/10.1186/s12967-015-0517-x |
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