Guidance Document on the Uterothrophic Bioassay ‑ Procedure to Test for Antioestrogenicity

This Guidance document focuses on the antioestrogenic protocol; it is the outcome of the experience gained during the validation test programme and the results obtained thereby with the use of a strong oestrogen receptor antagonist. Due to insufficient validation of this antioestrogenic protocol, this Guidance Document is provided for experimental purpose only. The test will provide supporting evidence in relation to antioestrogenic activity.