How to Regulate Nonbiological Complex Drugs (NBCD) and Their Follow-on Versions: Points to Consider

The aim of this critical review is to reach a global consensus regarding the introduction of follow-on versions of nonbiological complex drugs (NBCD). A nonbiological complex drug is a medicinal product, not being a biological medicine, where the active substance is not a homo-molecular structure, b...

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Autori principali: Schellekens, Huub, Stegemann, Sven, Weinstein, Vera, de Vlieger, Jon S. B., Flühmann, Beat, Mühlebach, Stefan, Gaspar, Rogério, Shah, Vinod P., Crommelin, Daan J. A.
Natura: Artigo
Lingua:Inglês
Pubblicazione: Springer US 2013
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Commentary
Accesso online:https://ncbi.nlm.nih.gov/pmc/articles/PMC3889532/
https://ncbi.nlm.nih.gov/pubmed/24065600
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1208/s12248-013-9533-z
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