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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...
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| Autori principali: | , , |
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| Natura: | Artigo |
| Lingua: | Inglês |
| Pubblicazione: |
Springer Berlin Heidelberg
2014
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| Soggetti: | |
| Accesso online: | https://ncbi.nlm.nih.gov/pmc/articles/PMC4046084/ https://ncbi.nlm.nih.gov/pubmed/24832831 https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1007/s10198-014-0589-1 |
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