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.
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
Download Forced degradation studies – comparison between …
Information
Domain:
Source:
Link to this page:
Please notify us if you found a problem with this document: