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2. ICH Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals M3 (Revision 2), 2009. ICH Web site.http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Multidisciplinary/M3_R2/Step4/M3_R2__Guideline.pdf(accessed Sept 20, 2013).
3. M3(R2) Guideline: Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals. Questions & Answers (R2), 2012. ICH Web site.http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Multidisciplinary/M3_R2/Q_As/M3_R2_Q_A_R2_Step4.pdf(accessed Sept 20, 2013).
4. Analytical strategies for identifying drug metabolites
5. Application of Mass Spectrometry for Metabolite Identification