caa a22 4500 378861743 CHVBK 20180305123348.0 cr unu---uuuuu 161128e20030101xx s 000 0 eng 10.1351/pac200375112605 doi (NATIONALLICENCE)gruyter-10.1351/pac200375112605 Endocrine disruption and the USFDA's Center for Drug Evaluation and Research [Elektronische Daten] [A. Jacobs, Paul Brown, James Farrelly, J. E. Fisher, D. Morse] Drugs may have intended or unintended endocrine effects. Drug evaluation may include both in vitro and in vivo evaluations of toxicity and developmental/reproductive effects. After a signal is identified, human relevance is of utmost concern. An integration "tool" that formalizes a weight-of-evidence approach has been developed to assess concern about reproductive/ developmental toxicity to humans. This approach can be used to assess concern about an endocrine disruption signal. A signal alone does not mean a concern for humans. An effect needs to have biologic relevance, and exposure thresholds for effects may exist. Risk/benefit for a particular drug is a clinical decision and may vary by the drug indication. Risk management for an identified concern could include wording in patient communications, tracking distribution or limited distribution, and patient or pregnancy registries. © 2013 Walter de Gruyter GmbH, Berlin/Boston Jacobs A. U.S.Food and Drug Administration, HFD-540 5600 Fishers Lane, Rockville, MD 20857,USA aut Brown Paul U.S.Food and Drug Administration, HFD-540 5600 Fishers Lane, Rockville, MD 20857,USA aut Farrelly James U.S.Food and Drug Administration, HFD-540 5600 Fishers Lane, Rockville, MD 20857,USA aut Fisher J. E. U.S.Food and Drug Administration, HFD-540 5600 Fishers Lane, Rockville, MD 20857,USA aut Morse D. U.S.Food and Drug Administration, HFD-540 5600 Fishers Lane, Rockville, MD 20857,USA aut Pure and Applied Chemistry De Gruyter 75/11-12(2003-01-01), 2605-2607 0033-4545 75:11-12<2605 2003 75 pac https://doi.org/10.1351/pac200375112605 text/html Onlinezugriff via DOI 1 research article jats NATIONALLICENCE 856 40 https://doi.org/10.1351/pac200375112605 text/html Onlinezugriff via DOI NATIONALLICENCE 700 1- Jacobs A. U.S.Food and Drug Administration, HFD-540 5600 Fishers Lane, Rockville, MD 20857,USA aut NATIONALLICENCE 700 1- Brown Paul U.S.Food and Drug Administration, HFD-540 5600 Fishers Lane, Rockville, MD 20857,USA aut NATIONALLICENCE 700 1- Farrelly James U.S.Food and Drug Administration, HFD-540 5600 Fishers Lane, Rockville, MD 20857,USA aut NATIONALLICENCE 700 1- Fisher J. E. U.S.Food and Drug Administration, HFD-540 5600 Fishers Lane, Rockville, MD 20857,USA aut NATIONALLICENCE 700 1- Morse D. U.S.Food and Drug Administration, HFD-540 5600 Fishers Lane, Rockville, MD 20857,USA aut NATIONALLICENCE 773 0- Pure and Applied Chemistry De Gruyter 75/11-12(2003-01-01), 2605-2607 0033-4545 75:11-12<2605 2003 75 pac CC0 http://creativecommons.org/publicdomain/zero/1.0 nationallicence BK010053 XK010053 XK010000 NATIONALLICENCE NATIONALLICENCE NL-gruyter