A carregar...
Interchangeability of Biosimilars: What Level of Clinical Evidence is Needed to Support the Interchangeability Designation in the United States?
A biosimilar is a biologic drug that is “highly similar to a reference (originator) product, with no clinically meaningful differences between the two products in safety, purity, and potency”. Regulatory approval of a biosimilar is based on analytical, structural, and functional comparisons with the...
Na minha lista:
| Publicado no: | BioDrugs |
|---|---|
| Main Authors: | , , , , |
| Formato: | Artigo |
| Idioma: | Inglês |
| Publicado em: |
Springer International Publishing
2020
|
| Assuntos: | |
| Acesso em linha: | https://ncbi.nlm.nih.gov/pmc/articles/PMC7669758/ https://ncbi.nlm.nih.gov/pubmed/32990892 https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1007/s40259-020-00446-7 |
| Tags: |
Adicionar Tag
Sem tags, seja o primeiro a adicionar uma tag!
|