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.
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:
Related search queries
Stability Testing of Pharmaceutical, Stability testing of pharmaceutical products, Stability, Study on the Energy Sector in Ethiopia, Generation Y in the Workforce, 5 – Quality (CMC) considerations, Analytical method, Importance, Status of selected physicochemical properties of, Status of selected physicochemical properties of soils, The race between machine and man, GUIDELINES ON STABILITY EVALUATION OF, Accelerated stability