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Forced degradation studies – comparison between …
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 .. 1 2. Forced degradation studies .. 2 Terms for Forced 2 Purpose of Forced degradation 2 3. Regulatory overview .. 4 ICH guidelines - regulatory overview .. 4 ICH Q1A Stability Testing of New Drug Substances and Products.
Page 1 1. Introduction and scope Forced degradation is an exposure of the drug substance or drug product to different stress conditions (more severe than accelerated conditions) [1] which results in relevant
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