Potential Mutagenic Impurity (GTI) Assessments
Impurities in drug substances and drug products typically arise from synthesis and/or are degradants. However, some impurities, which are highly reactive because of their structure, have the potential to interact with DNA.
A mutagenicity assessment must be performed for all confirmed impurity/degradant structures found during the scientific evaluation of investigational drug substances and products in order to comply with ICH M7 guidance. Arcinova has the capability to arrange these assessments using a range of different software tools.
Bio SpainBioSpain 2018 will be attended by Nathalie Huther, Business Development Manager Europe.
Bio SpainDates: 25th - 27th SeptemberLocation: Seville, Spain
BioForwardThe BioForward event will be attended by Nathalie Huther, Business Development Manager Europe.
BioForwardDates: 4th OctoberLocation: Birmingham, UK
CPhI WorldwideCPhI Worldwide will be attended by Nathalie Huther, Business Development Manager Europe. Nathalie will be located at the DIT stand: 9J40
CPhI WorldwideDates: 9th - 11th OctoberLocation: Madrid, Spain