1. FDA guidance for industry: Safety testing of drug metabolites,2008
2. International Conference on Harmonization. ICH Harmonized Tripartite Guideline: Guidance on M3 (R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals (2009).
3. European Medicines Agency. 2004. Committee for medicinal products for human use. Position paper on nonclinical safety studies to support clinical trials with a single microdose. CPMP/ SWP/ 2599/ 02/ Rev 1.
4. FDA guidance for industry. Exploratory IND studies. Guidance. US Department of Health and Human Services,2006
5. Guidance. Microdose clinical studies,2008