1. ICH official Web pages: http://www.ifpma.org/ich1.html; http://www.ifpma.org/ichMedDRA.html; http:// www.ifpma.org/ich5m.html.
2. MSSO official Web page: http://www.meddramsso.com.
3. Anonymous. Medical Dictionary For Regulatory Activities Terminology (MedDRA) Version 2.1: Introductory Guide. Technical document, included with the distribution of MedDRA Version 2.1, March 1999.
4. Anonymous: MedDRA ASCII File Information. Technical document. Included with the distribution of MedDRA Version 2.1, March 1999.
5. White CA. A Preliminary assessment of the impact of MEDDRA on adverse event reports and product labeling. Drug Inf J. 1998;32:347–362.