The European Agency for the Evaluation of Medicinal products,“Evaluation of Medicines for Human Use (EMEA), Position paper on non-clinical safety studies to support clinical trials with a single microdose”, CPMP/SWP/2599/02, 23 January 2003, Revised edition: CPMP/SWP/2599/02/Rev 1, London, 23 June, 2004.
U. S. Department of Health and Human Services, Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER),“Guidance for Industry, Investigators and Reviewers”, Exploratory IND Studies, 12January 2006.
U. S. Department of Health and Human Services, Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER),“Guidance for Industry, Bioanalytical Method Validation”, May 2001.