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Scientific and regulatory considerations for follow-on versions of complex drug products containing nanomaterials

18:55 EDT 4 May 2017 | Generics and Biosimilars Initiative

In this article [1], US Food and Drug Administration (FDA) scientists give a comprehensive overview of the nanomaterials presently available in the US and the challenges encountered when considering approval of generic (or follow-on) versions of these often complex drug products. More specifically, these challenges encompass ‘establishing active ingredient sameness, equivalence in the drug product physicochemical properties and equivalence in thein vivodrug exposure profiles between innovator and generic drug products’.

Original Article: Scientific and regulatory considerations for follow-on versions of complex drug products containing nanomaterials

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