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Statistical and regulatory considerations in assessments of interchangeability of biological drug products
When the patent of a brand-name, marketed drug expires, new, generic products are usually offered. Small-molecule generic and originator drug products are expected to be chemically identical. Their pharmaceutical similarity can be typically assessed by simple regulatory criteria such as the expectat...
| Autores principales: | , , |
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| Formato: | Online Artículo Texto |
| Lenguaje: | English |
| Publicado: |
Springer Berlin Heidelberg
2014
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| Materias: | |
| Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4046084/ https://www.ncbi.nlm.nih.gov/pubmed/24832831 http://dx.doi.org/10.1007/s10198-014-0589-1 |