Tibolone is a synthetic steroid hormone indicated for the prevention of postmenopausal osteoporosis and for the treatment of estrogen deficiency symptoms. Tibolone acts as an agonist primarily at estrogen receptors (ER) with a preference for ERα. It also possesses androgenic and progestogenic properties. The metabolites of tibolone are responsible for the effects in various tissues. Metabolites 3α- and 3β-hydroxy-tibolone both have estrogenic effects and the δ(4)-metabolite has progestogenic and androgenic effects. The specific tissue-selective effects of tibolone occur due to the metabolism, regulation of enzymes, and receptor activation that vary at different tissues. The bone-conserving effects are due to estradiol receptor activation and does not involve the progesterone and androgen receptors. In the uterus, the progestogenic activity of the δ(4)-metabolite and the effect on estrogen-inactivating enzymes prevent estrogenic stimulation.
Affygility Solutions has an occupational exposure limit (OEL) and control band assignment for this active pharmaceutical ingredient (API).
OEL Fastrac monographs are a cost-effective and convenient way to meet the requirements for PDEs (ADEs) contained in the EMA Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities (EMA/CHMP/CVMP/SWP/169430/2012), and to obtain the following information:
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Affygility Solutions’s OEL Fastrac service is an user-friendly system that enables us to make confident decisions and focus on moving the compound safely through our facility. We can quickly access the database to determine if a new drug is within the OEL Fastrac library, and if so, immediately download a detailed OEL banding report. The OEL Fastrac system has been a helpful tool in our overall EH&S program.