Implementation of Question-based Review in support of Quality by Design streamlining the US FDA’s review process

Abstract Question-based Review (QbR) is a format proposed by United States Food and Drug Administration (US FDA) enhancing the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use's Common Technical Document (ICH CTD) format to streamline the submi...

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Veröffentlicht in:	Journal of Generic Medicines 2018-09, Vol.14 (3), p.129-134
Hauptverfasser:	Desai, Alisha, Kumar Maji, Jayanta, Walavalkar, Kanhoba, Mehta, Priti J
Format:	Artikel
Sprache:	eng
Schlagworte:	Design of experiments Quality
Online-Zugang:	Volltext
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