Reproduction evaluations (female)
These evaluations identify toxic effects to NHP reproductive organs and mechanisms after exposure to the active pharmaceutical ingredient. These studies also assess potential changes in female cyclicity and possible functional effects that may be missed in the general toxicity testing. Evaluation of fertility is typically required before Phase III trials or in parallel. The data come from estrous-cycle evaluations, fertility assessments, and ovarian and uterine evaluations. Regulatory guidelines also often require organ weights and histopathology.