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...

Descripción completa

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

Ejemplares similares

Ejemplares similares