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Embryofetal development

Because the type I interferons produced no adverse effects on embryofetal development and the early abortifacient effect could be predicted based on a measurement of female endocrine changes, the need to conduct additional macaque embryofetal development studies for type I interferons in nonhuman primates was considered unnecessary. Therefore, for the second-generation pegylated versions of the alpha interferons, only hormonal analysis was conducted in macaques. This is the only known example of where mechanistic studies have been accepted in place of developmental studies in accordance with ICH S6 guidance. [Pg.361]

Note-. F = fertility, EFD = embryofetal development, and PPD = pre and postnatal development. [Pg.366]

The macaque embryofetal development study design has been shown to be appropriate for detecting the teratogenic effects of the small molecular weight drugs thalidomide and isotretinoin [35,36]. For large molecular weight biopharmaceuticals that do not cross the placenta the standard macaque... [Pg.373]

TABLE 18.6 Parameters for evaluation of embryofetal development in the nonhuman primate model... [Pg.389]

TABLE 18.7 Presumed advantages and disadvantages of the marmoset model for embryofetal development evaluation... [Pg.390]

Fuchs A, Weinbauer G. Feasibilty of embryofetal development studies in the marmoset (Callithrix jacchus). In Weinbauer G,VogelF,eds.NovelApproaches towards Primate Toxicology. Muenster Waxmann 2006 110-22. [Pg.396]

Embryofetal development mouse2 Pre- and postnatal development mouse2... [Pg.595]

Study for Effects on Embryofetal Development and Toxicokinetics in Rats (Segment 2)... [Pg.881]

Study for Effects on Embryofetal Development and Toxicokinetics in Rats (Segment 2) ICH S5 A Detection of Toxicity to Reproduction for Medicinal Products 4-6 8-12 100,000-125,000... [Pg.910]

See other pages where Embryofetal development is mentioned: [Pg.186]    [Pg.537]    [Pg.358]    [Pg.360]    [Pg.361]    [Pg.361]    [Pg.362]    [Pg.363]    [Pg.369]    [Pg.370]    [Pg.372]    [Pg.373]    [Pg.373]    [Pg.374]    [Pg.374]    [Pg.379]    [Pg.379]    [Pg.385]    [Pg.386]    [Pg.387]    [Pg.388]    [Pg.388]    [Pg.389]    [Pg.389]    [Pg.389]    [Pg.391]    [Pg.393]    [Pg.529]    [Pg.532]    [Pg.595]    [Pg.596]    [Pg.661]    [Pg.701]    [Pg.851]    [Pg.851]   


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Embryofetal development studies

Embryofetal development studies nonhuman primates

Nonhuman primates embryofetal development

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