1. ICH Harmonised Tripartite Guideline. Statistical principles for clinical trials. Stat Med. 1999;18:1905–1942.
2. Temple RJ. The regulatory evolution of the inte-grated safety summary. Drug Inf J. 1991;25:485–492.
3. FDA. Guideline for the format and content of the clinical and statistical sections of an application. Rockville, MD: US Food and Drug Administration; May 1988.
4. CDER draft reviewer guidance. Conducting a clinical safety review of a new product application and preparing a report on the review. Rockville, MD: US Food and Drug Administration, CDER; November 1996.
5. Chuang-Stein C. Safety analysis: Too much? Not enough? And How? ASA Biopharmaceutical Report. 1992;1%(3):1–11.