Proposal of International Council for Harmonization (ICH) Guideline for the Approval of Biosimilars

OBJECTIVES: Since the initial release of biosimilars 18 years ago, regulations for their licensing have changed considerably; however, there is no global consensus on these regulations. Establishing harmonized regulatory guidelines for the approval of biosimilars with support from the ICH, an indepe...

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Detalles Bibliográficos
Autores principales: Niazi, Sarfaraz K., Al-Shaqha, Waleed Mohammed, Mirza, Zafar
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Routledge 2022
Materias:
Research Article
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9677983/
https://www.ncbi.nlm.nih.gov/pubmed/36419638
http://dx.doi.org/10.1080/20016689.2022.2147286

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9677983/
https://www.ncbi.nlm.nih.gov/pubmed/36419638
http://dx.doi.org/10.1080/20016689.2022.2147286

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