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A ‘Global Reference’ Comparator for Biosimilar Development
Major drug regulators have indicated in guidance their flexibility to accept some development data for biosimilars generated with reference product versions licensed outside their own jurisdictions, but most authorities require new bridging studies between these versions and the versions of them lic...
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| Publicado no: | BioDrugs |
|---|---|
| Main Authors: | , |
| Formato: | Artigo |
| Idioma: | Inglês |
| Publicado em: |
Springer International Publishing
2017
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| Assuntos: | |
| Acesso em linha: | https://ncbi.nlm.nih.gov/pmc/articles/PMC5541093/ https://ncbi.nlm.nih.gov/pubmed/28526943 https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1007/s40259-017-0227-4 |
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