Caricamento...

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...

Descrizione completa

Salvato in:
Dettagli Bibliografici
Autori principali: Tóthfalusi, Lászlo, Endrényi, László, Chow, Shein-Chung
Natura: Artigo
Lingua:Inglês
Pubblicazione: Springer Berlin Heidelberg 2014
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
Tags: Aggiungi Tag
Nessun Tag, puoi essere il primo ad aggiungerne! !