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10 p, 3.5 MB Compliance in Non-Clinical Development of Cell-, Gene-, and Tissue-Based Medicines : Good Practice for Better Therapies / Lopez-Navas, Luís (Andalusian Network for the Design and Translation of Advanced Therapies. Andalusian Health Ministry) ; Torrents, Sílvia (Banc de Sang i Teixits. Edifici Dr. Frederic Duran i Jordà) ; Sánchez-Pernaute, Rosario (Andalusian Network for the Design and Translation of Advanced Therapies. Andalusian Health Ministry) ; Vives, Joaquin (Universitat Autònoma de Barcelona. Departament de Medicina)
The development of cell-, gene-and tissue engineering (CGT)-based therapies must adhere to strict pharmaceutical quality management standards, as for any other biological or small-molecule drug. However, early developments often failed to fully comply with good laboratory practices (GLP) in non-clinical safety studies. [...]
2022 - 10.1093/stcltm/szac046
Stem Cells Translational Medicine, Vol. 11 Núm. 8 (august 2022) , p. 805-813  

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