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11 p, 712.2 KB Extrapolation : Experience gained from original biologics / Rojas-Chavarro, Luisa Fernanda (Universitat Autònoma de Barcelona. Departament de Farmacologia, de Terapèutica i de Toxicologia) ; Mora Pérez, Fernando de (Universitat Autònoma de Barcelona. Departament de Farmacologia, de Terapèutica i de Toxicologia)
Biologicals undergo modifications throughout their commercial lifecycle. Major changes can unintentionally magnify their inherent physicochemical variability. Although trials comparing the pre- and the post-change versions have been requested occasionally, analytical comparison is the most sensitive approach to anticipating clinical equivalence. [...]
2021 - 10.1016/j.drudis.2021.05.006
Drug Discovery Today, Vol. 26 Núm. 8 (august 2021) , p. 2003-2013  
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