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Depósito Digital de Documentos de la UAB	Encontrados 2 registros	La búsqueda tardó 0.01 segundos.

5 p, 255.6 KB

Overlapping biosimilar and originator follitropin alfa preparations : How much closer can they get? / Mora Pérez, Fernando de (Universitat Autònoma de Barcelona. Departament de Farmacologia, de Terapèutica i de Toxicologia) ; Howles, Colin M. (ARIES Consulting, Geneva, Switzerland)
Unfounded skepticism relating to biosimilars, arising from the assertion that they are not molecularly identical to their original counterpart, fails to acknowledge that no biological medicine, including Gonal-f® (from Merck Serono) is identical to itself. [...]
2022 - DOI (Digital Object Identifier)

10.1016/j.drudis.2022.04.022
Drug Discovery Today, Vol. 27 Núm. 8 (august 2022) , p. 2071-2075

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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 - DOI (Digital Object Identifier)

10.1016/j.drudis.2021.05.006
Drug Discovery Today, Vol. 26 Núm. 8 (august 2021) , p. 2003-2013

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