Transcription of Forced degradation studies – comparison between ICH, EMA ...
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Forced degradation studies – comparison between ICH, EMA ...
Forced degradation studies comparison between ICH, EMA, FDA and WHO guidelines and ANVISA s resolution RDC 53/2015 Wissenschaftliche Pr fungsarbeit zur Erlangung des Titels Master of Drug Regulatory Affairs der Mathematisch-Naturwissenschaftlichen Fakult t der Rheinischen Friedrich-Wilhelms -Universit t Bonn vorgelegt von Helene Janzen aus Susanowo Bonn 2016 Page I Betreuer und 1. Referent: Prof. Dr. Usfeya Muazzam 2. Referent: Dr. Christin Selent-Stier Page II Table of Contents List of Figures .. IV List of Abbreviations .. V 1. Introduction and scope.
In the past years one of the national regulatory agencies - the Brazilian National Health Surveillance Agency (ANVISA) - has dedicated themselves to deal with the topic “forced degradation”. ANVISA has taken over a pioneering task in establishing further requirements and guidance in comparison to what is currently available.
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