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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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Detalhes bibliográficos
Main Authors: Tóthfalusi, Lászlo, Endrényi, László, Chow, Shein-Chung
Formato: Artigo
Idioma:Inglês
Publicado em: Springer Berlin Heidelberg 2014
Assuntos:
Acesso em linha: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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