Analytical sameness methodology for the evaluation of structural, physicochemical, and biological characteristics of Armlupeg: A pegfilgrastim biosimilar case study

Pegfilgrastim is administered as an adjunct to chemotherapy to reduce the incidence of febrile neutropenia and associated infectious complications. Lupin’s Pegfilgrastim is a proposed biosimilar to the U.S.-referenced Neulasta®. Demonstration of biosimilarity requires extensive physicochemical and f...

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Detalles Bibliográficos
Autores principales: Deshmukh, Arati, Goyal, Rishank, Sundaram, Kalyana, Dange, Kaustubh, Lakhote, Tejshri, Niranjan, Sanjay, Bharucha, Jennifer, Mishra, Ashok, Vats, Bhavesh, Tiwari, Sanjay
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Public Library of Science 2023
Materias:
Research Article
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10411777/
https://www.ncbi.nlm.nih.gov/pubmed/37556495
http://dx.doi.org/10.1371/journal.pone.0289745

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10411777/
https://www.ncbi.nlm.nih.gov/pubmed/37556495
http://dx.doi.org/10.1371/journal.pone.0289745

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