Regulatory Expectations on impurities in Drug Substances
Data:
02 ottobre 2015
Sede:
Università di Pavia
Pavia
Contenuti:
Scientific Program
Rules and reference guidances on impurities: the status of art
Expected approach in Developing Control Strategies for Impurities in Drug Substances Carry-over of impurities from materials for API Synthesis
Impurities in Drug Substances prepared via fermentation and other bio-processes
Impurities in Biological Drug Substances
Impurities in Drug Substances of vegetable origin
Genotoxicity, mutagenic and carcinogenic risk related to impurities
Strategies to minimize the impact of presence of residual solvents in APIs
Elemental impurities impact on APIs
Impurities from degradation of Drug Substances
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