Registration Dossier

Diss Factsheets

Administrative data

basic toxicokinetics in vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
Justification for type of information:
Estrone is an endogenous sex hormone and an approved drug since several decades. The active ingredient, synthetic estrone, is similar both chemically and biologically to endogenously produced human estrone. Estrone belongs to the category “steroidal estrogens” and is one of the pharmacologically less-active metabolites of 17β-estradiol which is the most biologically potent estrogen.

The pharmacokinetics and metabolism of 17β-estradiol in animals is well characterized as described in the literature*.

* Kuhnz W, Blode H, Zimmermann H. Pharmacokinetics of exogenous natural and synthetic estrogens
and antiestrogens. In: . Oettel M, Schillinger E, eds. Handbook of Experimental Pharmacology,
Estrogens and Antiestrogens II. Berlin: Springer Verlag, 1999:261-322

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion