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Assessment of Availability, Clinical Testing, and US Food and Drug Administration Review of Biosimilar Biologic Products
IMPORTANCE: Biosimilar biologic products were authorized in 2010, after the US Congress established an expedited pathway for approval of clinically similar versions of approved biologic products. Unlike for most small-molecule generic drugs, approval requirements for a biosimilar included animal stu...
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| Publicado no: | JAMA Intern Med |
|---|---|
| Main Authors: | , , , , |
| Formato: | Artigo |
| Idioma: | Inglês |
| Publicado em: |
American Medical Association
2021
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| Assuntos: | |
| Acesso em linha: | https://ncbi.nlm.nih.gov/pmc/articles/PMC7536628/ https://ncbi.nlm.nih.gov/pubmed/33031559 https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1001/jamainternmed.2020.3997 |
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