Výsledky vyhledávání - "Kathleen, Uhl"

Adverse effects in women: implications for drug development and regulatory policies

Autor: Douglas C. Throckmorton, Kathleen Uhl, Ameeta Parekh, Emmanuel O. Fadiran

Publikováno v: Expert Review of Clinical Pharmacology. 4:453-466

The requirement to establish safety of drugs prior to marketing has been in place since 1938 by the US Food, Drug and Cosmetic Act and is by no means a new concept. The efficacy regulations were enacted in 1962 via the Kefauver-Harris Amendment and t

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::25596250ebd6043abe476c6ead36bd9f
https://doi.org/10.1586/ecp.11.29

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Evaluation of ventricular arrhythmias in early clinical pharmacology trials and potential consequences for later development

Autor: Robert Kleiman, Jay W. Mason, Peter R. Kowey, J. Rick Turner, Kathleen Uhl, Mitchell W. Krucoff, Sherene S. Min, Christopher Newton-Cheh, John Finkle, Robert Pordy, Ivo Hynie, Alex Phipps, Adel Nada, Tara L. Dimino, Shari L. Targum, Colette Strnadova

Publikováno v: American Heart Journal. 159:716-729

This white paper, prepared by members of the Cardiac Safety Research Consortium, discusses several important issues regarding the evaluation of ventricular arrhythmias in early clinical pharmacology trials and their potential consequences for later c

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::2ccad5d03f6cca67dee990719389d271
https://doi.org/10.1016/j.ahj.2010.02.004

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Pharmacotherapy for Depressed Pregnant Women: Overcoming Obstacles to Gathering Essential Data

Autor: Kathleen Uhl, Paul S. Appelbaum, Katherine L. Wisner, S F Goldkind

Publikováno v: Clinical Pharmacology & Therapeutics, 86(4), 362-365. Nature Publishing Group

Approximately 3% of pregnant women take antidepressant medications. Information on the impact of antidepressants on short- and long-term maternal and offspring outcomes is highly desirable but neglected. The position that the dearth of treatment info

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::979af40897d9cad98135f90220df1372
https://doi.org/10.1038/clpt.2009.160

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Improving Women's Health Through Modernization of Our Bioinformatics Infrastructure

Autor: Kathleen Uhl, A Oliva, Robert L. Levin, Ellen Pinnow

Publikováno v: Clinical Pharmacology & Therapeutics. 83:192-195

Our nationwide bioinformatics infrastructure used to detect important sex differences associated with medical product use is antiquated. The Food and Drug Administration (FDA) has embarked on an ambitious bioinformatics modernization effort that will

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::94ee374d41f8a0124f3750ad22d06d99
https://doi.org/10.1038/sj.clpt.6100437

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The Food and Drug Administration Office of Women's Health: Impact of Science on Regulatory Policy

Autor: Dulce, Obias-Manno, Pamela E, Scott, Joseph, Kaczmarczyk, Margaret, Miller, Ellen, Pinnow, Lynda, Lee-Bishop, Michelle, Jones-London, Kennerly, Chapman, Deborah, Kallgren, Kathleen, Uhl

Publikováno v: Journal of Women's Health. 16:807-817

In 1994, the Food and Drug Administration Office of Women's Health (FDA-OWH) was created to provide leadership and policy direction for the Agency regarding issues of women's health. Within its first year, the FDA-OWH established a science program fo

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::e63dc3dba9619fcc5816855b99727a26
https://doi.org/10.1089/jwh.2006.0135

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Risk minimization practices for pregnancy prevention: understanding risk, selecting tools

Autor: Dianne L. Kennedy, Kathleen Uhl, Anne Trontell

Publikováno v: Pharmacoepidemiology and Drug Safety. 16:337-348

According to the March of Dimes, approximately 4% (1/28) of babies are born in the US each year with a birth defect. For the majority of birth defects the etiology is unknown, although chemicals, including drug exposures, probably account for less th

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::6822020e37de852d8e550d9169889b29
https://doi.org/10.1002/pds.1312

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Antibiotic Use in Pregnancy and Lactation

Autor: Dianne L. Kennedy, Kathleen Uhl, Gerard G. Nahum

Publikováno v: Obstetrics & Gynecology. 107:1120-1138

Over ten million women are either pregnant or lactating in the United States at any time. The risks of medication use for these women are unique. In addition to normal physiologic changes that alter the pharmacokinetics of drugs, there is the concern

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::512bd7832d27c10e6ea394e050c1360f
https://doi.org/10.1097/01.aog.0000216197.26783.b5

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