Fertility study

Toxicological Fertility study (one generation) Embryotoxicity (one species) Subchronic/chronic toxicity (one species) Additional mutagenicity... [Pg.321]

Toxicological Chronic toxicity Carcinogenicity Fertility study (multi-generation) Embryotoxicity (non-rodent) Acute/subacute toxicity in 2nd species Toxicokinetics... [Pg.321]

Bertoli D, Borelli G Fertility study of rifaximin (L/105) in rats. Chemioterapia (Florence) 1986 5 204-207. [Pg.66]

In vivo mutagenicity studies Further repeat-dose study in the rat Second developmental toxicity study Two-generation fertility study in the rat Chronic fish toxicity study Biodegradation simulation studies... [Pg.13]

Long-term repeat-dose (a 12 months) study in the rat Further toxicity study to investigate specific concerns Two-generation fertility study in the rat (if not part of the Annex VII data)... [Pg.14]

Segment 1 Fertility studies in the rat or mouse species used in the segment 2 program ... [Pg.84]

For all the options described above, effects on male and female fertility can be evaluated separately by conducting separate studies in which only one sex is treated. The treatment periods are the same, but the treated animals are cohabited with untreated animals of the opposite sex. In the male fertility study, the untreated females are terminated after the middle of gestation and terminal observations include embryo survival and possibly external examination of fetuses (if terminated at the end of gestation) (Tanimura, 1990). The advantage of conducting separate male and female studies is that, if there are effects, is it clear which sex was affected by treatment. Often when effects are seen in a combined male and female study, additional work is required to resolve which sex was affected. Either a second cohabitation of the treated males with untreated females is added or studies with only one sex treated must then be conducted. [Pg.266]

Not only is it difficult to detect effects on male fertility because of group-size considerations, effects on male fertility mediated by decreased sperm production are also difficult to detect because of the normally huge excess of sperm included in a rat ejaculate. Sperm production can be decreased by up to 90% without effect on fertility (either pregnancy rate or litter size) in the rat. This is not the case for men, so the sperm excess in the rat represents a serious flaw in the rat model (see Working, 1988). To address this deficiency and improve the sensitivity of the model, it is advisable to determine the effects of the test agent on testes weights, testicular spermatid counts, and histopathology of the testes (preferably plastic sections) in the male fertility study and/or the 14-week toxicity study. In some cases, these parameters may be more predictive of possible effects on male fertility in humans than the fertility rate in rats. [Pg.278]

Food consumption Toxicokinetics For fertility studies In-life observations Terminal and necroscopic evaluations For embryo-fetal development studies In-life observations... [Pg.423]

If peri-postnatal tests, developmental neurotoxicity smdies, or specific male or female fertility studies are available they can be used to identify a substance as being toxic to reproduction. Data from such studies alone cannot be used to identify a substance as being of no concern in relation to reproduction. [Pg.187]

Reproductive toxicity tests are not required to support Phase I clinical studies in men. Detailed histological evaluations of the male reproductive organs should be performed in the repeated-dose toxicity studies. Male fertility studies in the rodent, however, would be expected to support Phase III studies. [Pg.129]

Vallies J et al A two-generation reproduction-fertility study of cyanamide in the rat. Pharmacol Toxicol 61 20-25, 1987... [Pg.190]

Venable JR et al A fertility study of male employees engaged in the manufacture of glycerine. J Occup Med 22 87-91, 1980... [Pg.295]

Fertility Impairment In a fertility study in rats, estrous cyclicity was disrupted and numbers of corpora lutea, implantations, and live embryos were reduced in females receiving the highest dose (approximately 2 times the maximum recommended human dose on a mg/m basis). [Pg.1277]

As with the fertility study only one species is required, and the rat is the most commonly used species. The duration of treatment begins where the fertility study leaves off and continues through the lactation period (i.e., GD 6 to LD 21). The dams are allowed to deliver naturally, and all pups are evaluated at birth for external abnormalities and viability. Pups continue to be housed with their mothers until weaning (LD 21 = PND 21). Most laboratories reduce the number of pups per litter on PND 3 (or 4) and 21 however, it is also acceptable to retain all pups. [Pg.6]

These sections suggest the possibilities of performing a reduced number of studies. Both sections mention the combination of the fertility study and the PPN study. However, as previously discussed... [Pg.9]

However, in that combination study there is the potential risk of having effects on fertility in one or both sexes that would limit the number of litters available for evaluation of fetal morphology. The need to assess two species in the EFD study, to access both sexes in the fertility study, and the complexities of the PPN study make the three-study option the most practical and least risky. [Pg.9]

Lerman SA, Hew KW, Stewart J, Stump DG, Wise LD (2009) The nonclinical fertility study design for pharmaceuticals. Birth Defects Res B Dev Reprod Toxicol 86 429-436... [Pg.11]

Male fertility study I, II, III in male volimteers/patients ... [Pg.25]

Historical control data for fertility studies at Ricerca Biosciences with CrI Wistar rat body weight gain (g)... [Pg.131]

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