The Predictive Value of Non-Clinical Testing

5. Toxicology Studies

5.6. Reproduction Toxicity Studies

Reproduction toxicity studies test how the medicine may influence the ability to reproduce and develop normally. How these studies are carried out depends on the study population, and the following considerations:

  • Men can be included in Phase I and II clinical trials before the male fertility study, becausethe reproductive organs are evaluated in the repeated-dose toxicity studies. A male fertility study should be completed before initiatinglarge scale or long clinical trials (for instance, Phase III trials).

  • Women who are not of childbearing potential (for instance permanently sterilised or postmenopausal women) can take part in clinical trials without reproduction toxicity studies. In this case, the relevant repeated-dose toxicity studies must be completed beforehand (these studies include an evaluation of the female reproductive organs).

  • If women of childbearing potential (or WOCBP) are potential users of the medicine, reproduction toxicity studies need to be done as early as possible.