Reproduction Evaluations (male)
Nonclinical evaluation of the male reproductive system is a standard part of the safety assessment during drug development. Evidence of adverse, drug-related findings in animal models can inform the need for testicular toxicity evaluation in men.
Assessing active pharmaceutical ingredients for their potential to cause male reproductive toxicity involves the evaluation of data from experimental, epidemiological and mechanistic studies.
Histopathological, hormonal and semen parameter evaluations are the most used methods to assess testicular and pharmacological drug genotoxicity.
Evaluation of testicular cell proliferation, changes in gene and protein expression or epigenetic regulation can also be useful.