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Pharmacokinetic/Pharmacodynamic Modeling to Support the Re‐approval of Gemtuzumab Ozogamicin

Gemtuzumab ozogamicin (Mylotarg; Pfizer, New York, NY) was the first antibody–drug conjugate to be approved for CD33‐positive acute myeloid leukemia (AML). However, it was voluntarily withdrawn from the US market due to lack of clinical benefit in the confirmatory phase III trial. In 2012, several i...

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Detalles Bibliográficos
Autores principales: Fostvedt, Luke K., Hibma, Jennifer E., Masters, Joanna C., Vandendries, Erik, Ruiz‐Garcia, Ana
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6852000/
https://www.ncbi.nlm.nih.gov/pubmed/31070776
http://dx.doi.org/10.1002/cpt.1500