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Drug Regulatory-Compliant Validation of a qPCR Assay for Bioanalysis Studies of a Cell Therapy Product with a Special Focus on Matrix Interferences in a Wide Range of Organ Tissues

Quantitative polymerase chain reaction (qPCR) has emerged as an important bioanalytical method for assessing the pharmacokinetics of human-cell-based medicinal products after xenotransplantation into immunodeficient mice. A particular challenge in bioanalytical qPCR studies is that the different tis...

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Detalles Bibliográficos
Autores principales: Schröder, Hannes M., Niebergall-Roth, Elke, Norrick, Alexandra, Esterlechner, Jasmina, Ganss, Christoph, Frank, Markus H., Kluth, Mark A.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10340683/
https://www.ncbi.nlm.nih.gov/pubmed/37443822
http://dx.doi.org/10.3390/cells12131788