1. Regulatory Highlights
2. ICH M7 Step 4 June 2014, Assessment and Control of DNA Reactive (Mutagenic) Impurities In Pharmaceuticals To Limit Potential Carcinogenic Risk.http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Multidisciplinary/M7/M7_Step_4.pdf.
3. Guidance for Industry - Q3A (R2) Impurities in New Drug Substances, 25 October 2006.http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q3A_R2/Step4/Q3A_R2__Guideline.pdf.
4. ICH S9 Nonclinical Evaluation For Anticancer Pharmaceuticals.http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Safety/S9/Step4/S9_Step4_Guideline.pdf.
5. Risk Assessment of Genotoxic Impurities in New Chemical Entities: Strategies To Demonstrate Control