Reproductive toxicology studies

Ladies, G.S., et al., Developmental Toxicology Evaluations - Issues with including neurotoxicology assessments in reproductive toxicology studies, Toxicol. Sci., 88, 24, 2005. 

SOT sunset session Developmental toxicology Issues with including neurotox and immunotox assessments in reproductive toxicology studies. New Orleans, LA March, 2005... 

Mast TA, Rommerein RL, Evan off JJ, et al. 1989b. Inhalation reproductive toxicology studies Male dominant lethal study of n-hexane in Swiss (CD-I) mice. Department of Energy, Washington DC. NTIS No.-DE89000271. PNL-6679. 

CheUman GRet al (2009) Developmental and reproductive toxicology studies in nonhuman primates. Birth Defects Res B Dev Reprod Toxicol 83 1-17... 

Before reproductive toxicology studies are begun, the pharmacokinetic properties and indices of a compound in animals should be available. The distribution of the compound should be described adequately to permit the assessment of risk to the gonads and... 

For women who are of childbearing potential, the risks can be evaluated in reproductive toxicology studies and steps taken to minimize those risks. Alternatively, stringent contraceptive requirements can be incorporated into the clinical protocol to prevent the occurrence of pregnancy in the participants, although in practice, contraception is usually specified in all cases. Any risks should be... 

Safety assessment scientists and technicians and even QA personnel sometimes overlook the importance of environmental control equipment to valid study results. Animals stressed by extremes of temperature or humidity may 5ueld spurious data reproductive toxicology studies may be compromised by malfunctioning timers for the control of light/ dark cycles inadequate air filtration may expose experimental animals to environmental contaminants that confound experimental results. 

Reproductive Toxicity. No reproductive toxicological studies were located in the surveyed literature for HDI. Only a few animal studies examined the reproductive organs of both male and female animals, with no gross or histologieal results evident (Mobay Corporation 1984, 1988, 1989) none of the human studies of acute, intermediate, or ehronie durations directly addressed the issue of reproductive toxieity. The majority of studies used male humans and animals, presumably because hmnan males are presently the predominant sex in the automotive painting industry and, therefore, more likely to be exposed to HDI. 

Carcinogenicity tests and reproductive toxicology studies lasting up to two years. 

Previous reproductive toxicology studies in laboratory animals examining the effects of prenatal exposure to fumonisin demonstrated a potential risk to the developing fetus. Studies using an aqueous extract of contaminated maize-culture material of F. verticillioides reported that fumonisin was developmentally toxic in hamsters (Floss et al., 1994 Penner et al., 1998). In addition, purified fumonisin Bi was shown experimentally to cause fetal toxicity in rats and mice (Collins et al., 1998 Reddy et al., 1996). In another study, pregnant CD1 mice treated with a semipurified extract... 

It should be noted that there are very few CROs that offer reproductive toxicity testing in nonhuman primates. To date, most of the reproductive toxicology studies in monkeys have been segment 2 (teratology) studies. Segment 1 (fertility) studies would be difficult to conduct. 

Meyer JK, Fitzsimmons D, Hastings TF, Chellman GJ. Methods for the prediction of breeding success in male cynomolgus monkeys (Macaca fascicularis) used for reproductive toxicology studies. J Am Associ Lab Animal Sci 2006 45 31-6. 

Reproductive toxicology studies are conducted to reveal the effect of the drug candidate on mammalian reproduction and whether potential reproductive risks may exist for humans. These reproductive studies commonly use pregnant rats and rabbits as the test species. To ensure that the dams and the fetuses are appropriately exposed to the drug candidate and metabolites (11), the dams can be dosed with radiolabeled compound, and the amount of radioactivity that crosses the placenta and into the fetuses at various times after dosing can be... 

Predictive assessment of developmental and reproductive toxicology studies... 

Thalidomide demonstrated the need to evaluate new drugs in reproductive toxicology studies. Some of the earliest guidelines were issued by the US FDA (the Goldenthal guidelines ). An ICH guideline now covers the performance of these studies (Federal Register, 22 September 1994), as amended in 1995 to address possible effects on male reproduction. 

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