The purpose of this symposium is to educate the scientists working in the various areas of research and regulation in developmental and reproductive toxicology regarding differences and commonalities in regulatory needs and concerns. Multiple agencies and professional societies are attempting to develop guidelines for performing safety evaluations that will allow single tests to meet the requirements of more than one agency in order to reduce animal usage and decrease testing costs. This presentation, and the two that follow, describe some of the problems addressed, the approaches used, and the current regulatory requirements of Japan and the U.S. EPA.
References
1.
1. Christian, M.S., and Hoberman, A. M. (1989). Current in vivo reproductive and developmental toxicity (teratology) test methods. In: Marquis, J. K., ed. A Guide to General Toxicology, 2nd Ed. S. Karger, Basel, pp. 91–100
2.
2. Deichmann, W.B., Henschler, D., Holmsted, B., and Keil, G. (1986). What is there that is not poison? A study of the Third Defense by Paracelsus.Arch. Toxicol.58:207–213.
3.
3. Fda. (1966). Guidelines for Reproductive Studies for Safety Evaluation of Drugs for Human Use.Washington, Dc: Fda.
4.
4. U.S. Code (1988). Vol. 21, Section 201.57.
5.
5. Wilson, J.G. (1973). Environment and Birth Defects.New York: Academic Press, pp. 11–34
6.
6. Fda. (1982). Toxicological Principles for the Safety Assessment of Direct Food Additives and Color Additives Used in Food. National Technical Information Services, Pb83-170696, pp. 80-119.
7.
7. Epa. (1989). Proposed amendments to the guidelines for the health assessment of suspect developmental toxicants; Request for comments; Notice.Fed. Reg.54:(42), 9386–9403.
8.
8. Scientific Advisory Panel Subpanel On Reproductive Toxicity (February 22, 1989). Capitol Reporters, pp. 81-106.
9.
9. Committee On The Safety Of Medicines (1974). Notes for Guidance on Reproduction Studies.Department of Health and Social Security, Great Britain.
10.
10. Sullivan, F.M. (1983). Proceedings of the 11th Conference of the European Teratology Society.Paris.
11.
11. Japan. (1984). Notification No. 118 of the Pharmaceutical Affairs Bureau, Infomation on the Guidelines of Toxicity Studies Required for Application for Approval to Manufacture (Import) Drugs. Ministry of Health and Welfare. Japan.
12.
12. Pma Guidelines. (revised 1981). Reproduction, Teratology and Pediatrics. Contributors: Christian. M., Diener. R., Hoar, R. and Staples, R., Washington: Pharmaceutical Manufacturers Association.
