Segment II study

Phase I dosing of females if childbearing potential requires a Segment II study in at least one species Phase III dosing of this population requires a Segment I study and both Segment II studies. 

The dosing period of the pregnant animals during studies on embryonic development (traditional Segment II studies) has been standardized. 

Female reproduction and II, III involving female patients of Segment II studies in 2 species... 

These studies need to be carried out for all drugs proposed to be studied or used in women of child-bearing age. Segment 1,11, and III studies (see below) are performed in albino mice or rats, and segment II studies should also include albino rabbits as a second test species. 

ICH 4.1.3 Assessment of Developmental Toxicity. This is almost identical to the segment II study protocol. Pregnant animals are exposed from implantation through organogenesis. The parameters measured in the segment II study are similar. However, the study is usually conducted using at least two species. More specifically, at least one rodent and one nonrodent species. 

The third study design (Figure 4c), titled Study for Effects on Embryo-Fetal Development, is essentially an FDA Segment II study with exposure of the mother during organogenesis of her offspring in utero (gd 6-15). 

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