REPRODUCTIVE TOXICITY TESTING OF PHARMACEUTICAL COMPOUNDS TO SUPPORT THE INCLUSION OF WOMEN IN CLINICAL-TRIALS

1 The potential for toxicity to reproduction and the developing fetus is an important concern requiring attention during the development of new medicines. However, there are differences in the opinions of the r egulatory authorities in Europe, Japan and the USA regarding the natur e and amount of data from reproductive toxicity tests that should be a vailable at the various stages of clinical development. 2 Forty-one co mpanies or their subsidiaries from Europe, Japan and the USA provided data for a questionnaire-based study, carried out in 1994, to ascertai n the practices of pharmaceutical companies and their views on an idea l approach to the timing of reproduction and development toxicity stud ies in relation to clinical investigation. 3 Differences were identifi ed in the stage of drug development at which animal studies were compl eted, the sequence of completion of specific studies, and the extent o f reproduction testing completed to support the inclusion of women in clinical trials. 4 A harmonised, but flexible, guideline, encompassing the timing of reproductive toxicity studies in relation to clinical t rials, would permit better integration between clinical and non-clinic al studies in an international drug development programme.