Bioanalytical strategy used in development of pharmacokinetic (PK) methods that support biosimilar programs

The development of biosimilar products is expected to grow rapidly over the next five years as a large number of approved biologics reach patent expiry. The pathway to regulatory approval requires that similarity of the biosimilar to the reference product be demonstrated through physiochemical and s...

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Detalles Bibliográficos
Autores principales: Colbert, Alex, Umble-Romero, Amber, Prokop, Samantha, Chow, Vincent Fung-Sing, Wong, Teresa, DeSimone, Danielle, Zhou, Lei, Pederson, Susan
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Taylor & Francis 2014
Materias:
Reports
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4623269/
https://www.ncbi.nlm.nih.gov/pubmed/25517303
http://dx.doi.org/10.4161/mabs.32114

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4623269/
https://www.ncbi.nlm.nih.gov/pubmed/25517303
http://dx.doi.org/10.4161/mabs.32114

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