Recent developments in regulatory requirements for developmental toxicology
Tài liệu tham khảo
Faber, 1991, Does the Chernoff-Kavlock screening assay for developmental toxicity detect developmental neurotoxicants?, Toxicologist, 11, 345A
Food and Drug Administration (FDA), 1966. Guidelines for Reproduction Studies for Safety Evaluation of Drugs for Human Use.
Food and Drug Administration (FDA), 1982. Toxicological principles for the safety assessment of direct food additives and color additives used in food (Redbook I), NTIS No. PB83-170696 (available from NTIS, Springfield, VA).
Food and Drug Administration (FDA), 1998a. Regulations requiring manufacturers to assess the safety and effectiveness of new drugs and biological products in pediatric patients. Fed. Regist. 63, 66632–66672.
Food and Drug Administration (FDA), 1998b. Draft list of drugs for which additional pediatric information may produce health benefits in the pediatric population. Docket No. 98N0056, 1–20.
Food and Drug Administration (FDA), 2000. Toxicological Principles for the Safety of Food Ingredients, Redbook 2000, US Food and Drug Administration, Center for Food Safety and Applied Nutrition, July 7, available at http://vm.cfsan.fda.gov/∼redbook/red-toct.html.
Goldey, 1995, Implications of the use of neonatal birth weight, growth, viability, and survivial data for predicting developmental neurotoxicity: a survey of the literature, Neurotoxicol. Teratol., 17, 313, 10.1016/0892-0362(94)00073-M
International Conference on Harmonisation (ICH), 1994. ICH-S5A. Detection of toxicity to reproduction for medicinal products. Fed. Regist. 59(183), 48746–48752.
International Conference on Harmonisation (ICH), 1996. ICH-S5B. Detection of toxicity to reproduction for medicinal products: addendum on toxicity to male fertility. Fed. Regist. 61, 15359–15361.
Kimmel, C.A., 2001. US EPA Reference Dose/Reference Concentration methodology: Update on a review of the process. Human Ecolog. Risk Assess. (in press).
Kimmel, C.A., Kimmel, G.L., Frankos, V., Eds., 1986. Interagency Regulatory Liaison Group workshop on reproductive toxicity risk assessment. Environ. Health Perspect. 66, 193–221.
Kimmel, 1990, Qualitative and quantitative comparability of human and animal developmental neurotoxicity, Neurotoxicol. Teratol., 12, 173
Makris, S., Raffaele, K., Sette, W., Seed, J., 1998. A retrospective analysis of twelve developmental neurotoxicity studies (OPPTS). (November 12, 1998 draft), available at http://www.epa.gov/scipoly/sap/1998/index.htm#december8.
National Research Council (NRC), 1993. Pesticides in the Diets of Infants and Children. National Academy Press, Washington, DC.
Organization for Economic Cooperation and Development (OECD), 1981. Guideline 414: Teratogenicity.
Organization for Economic Cooperation and Development (OECD), 1983. Guideline 416: Two generation reproduction toxicity.
Organization for Economic Cooperation and Development (OECD), 1999. Guideline 426: Developmental neurotoxicity study (draft, October, 1999), available at http: www.oecd.org/ehs/test/health.htm..
Organization for Economic Cooperation and Development (OECD), 2000. Guideline 414: Prenatal developmental toxicity study (approved draft, June 2000), available at http: www.oecd.org/ehs/test/health.htm.
Organization for Economic Cooperation and Development (OECD), 2000. Guideline 416: Two-generation reproduction toxicity study (approved draft, June 2000), available at http: www.oecd.org/ehs/test/health.htm.
Ulbrich, 1996, Neurobehavioral aspects of developmental toxicity testing, Environ. Health Perspect., 104, 407, 10.1289/ehp.96104s2407
US Environmental Protection Agency (USEPA), 1982. Pesticides assessment guidelines, subdivision F. Hazard evaluation: human and domestic animals, EPA-540/9-82-025, (available from NTIS, Springfield, VA).
US Environmental Protection Agency (USEPA), 1985. Toxic Substances Control Act test guidelines; final rules. Fed. Regist., 50, 39426–39428 and 39433–39434.
US Environmental Protection Agency (USEPA), 1986. Guidelines for the health assessment of suspect developmental toxicants. Fed. Regist. 51, 34028–34040.
US Environmental Protection Agency (EPA), 1991a. Guidelines for developmental toxicity risk assessment; notice. Fed. Regist., 56, 63798–63826.
US Environmental Protection Agency (EPA), 1991b. Pesticide assessment guidelines, subdivision F. Hazard evaluation: human and domestic animals. Addendum 10: Neurotoxicity, series 81, 82, and 83. Office of Prevention, Pesticides and Toxic Substances, Washington, DC. EPA 540/09-91-123 (available from NTIS, Springfield, VA. PB91–154617).
US Environmental Protection Agency (USEPA), 1996. Reproductive toxicity risk assessment guidelines; notice. Fed. Regist., 61, 56274–56322.
US Environmental Protection Agency (USEPA), 1998a. Guidelines for neurotoxicity risk assessment; notice. Fed. Regist. 63, 26926–26954.
US Environmental Protection Agency (USEPA), 1998b. Health Effects Test Guidelines, OPPTS 870.3700, Prenatal Developmental Toxicity Study, EPA 712-C-98-207, available at http://www.epa.gov/opptsfrs/home/guidelin.htm.
US Environmental Protection Agency (USEPA), 1998c. Health Effects Test Guidelines, OPPTS 870.3800, Reproduction and Fertility Effects, EPA 712-C-98-208, available at http://www.epa.gov/opptsfrs/home/guidelin.htm.
US Environmental Protection Agency (USEPA), 1998d. Health Effects Test Guidelines, OPPTS 870.6200, Neurotoxicity Screening Battery, EPA 712-C-98-238, available at http://www.epa.gov/opptsfrs/home/guidelin.htm.
US Environmental Protection Agency (USEPA), 1998e. Health Effects Test Guidelines, OPPTS 870.6300, Developmental Neurotoxicity Study, EPA 712-C-98-239, available at http://www.epa.gov/opptsfrs/home/guidelin.htm.
US Environmental Protection Agency (USEPA), 1999a. The Office of Pesticide Program's policy on determination of the appropriate FQPA safety factor(s) for use in the tolerance-setting process. (May 10, 1999 draft), available at http://www.epa.gov/scipoly/sap/1999/index.htm#may.
US Environmental Protection Agency (USEPA), 1999b. The Office of Pollution Prevention and Toxics’ Proposed Test Battery for the Children's Health Testing Program, Presentation to the FIFRA Scientific Advisory Panel, May 25, 1999, available at http://www.epa.gov/scipoly/sap/index.htm.
US Environmental Protection Agency (USEPA), 1999c. Toxicology data requirements for assessing risks of pesticide exposure to children's health-Report of the Toxicology Working Group of the 10X Task Force (April 28, 1999 draft), available at http://www.epa.gov/scipoly/sap/1999/index.htm#may.
USEPA, 2000. Framework for a Voluntary Children's Chemical Evaluation Program (April 10, 2000 draft). available at http://www.epa.gov/chemrtk/kdsfr410.htm.