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                OWH-Funded Research

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          Peer-Reviewed Scientific PublicationsOWH-Funded Research Peer-Reviewed Scientific Publications
  
  					From the FDA Office of Women's Health
	
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    PrintFDA Office of Women’s Health (OWH) staff and OWH-funded researchers are working to advance the science of sex differences and foster a greater understanding of FDA’s policies and initiatives in this area.

**Open the sections below to browse publications by OWH staff**

2022 - present
	*Journal (full paper):*

Zhou S, Qi K, Nugent BM, Bersoff-Matcha SJ, Struble K. Participation of HIV-1 infected treatment-naive females in clinical trials and sex differences in efficacy and safety outcomes. *AIDS*. 2023;37(6):895-903. doi: 10.1097/QAD.0000000000003478
	Head SK, Doamekpor LA, South EM, Louie C, Stanislav Z, Vasisht K, Bersoff-Matcha S. Behaviors related to medication safety and use during pregnancy. *Journal of Womens Health*. 2023;32(1):47-56. doi:10.1089/jwh.2022.0205
	Doamekpor LA, Head SK, South EM, Louie C, Stanislav Z, Vasisht K, Bersoff-Matcha S. Determinants of hormone replacement therapy knowledge and current hormone replacement therapy use. *Journal of Womens Health*. 2023;32(3):283-292. doi:10.1089/jwh.2022.0342


2018 - 2021
	*Journal (commentary):*

Vasisht KP, Nugent BM, Woodcock J. Progress and opportunities for women in clinical trials: a look at recent data and initiatives from the US FDA. *Med*. 2021;2(5):456-459. doi: 10.1016/j.medj.2021.04.010*Journal (full paper):*

Duggal M, Sacks L, Vasisht, KP. Eligibility criteria and clinical trials: an FDA perspective. *Contemporary Clinical Trials*. 2021; 109:106515. doi: 10.1016/j.cct.2021.106515
	Jenkins MR, Munoz MA, Bak D, Chai G, Ready T, South EM, Zinn RL, Zusterzeel R, Woodcock J. Food and Drug Administration Beyond the 2001 Government Accountability Office Report: Promoting Drug Safety for Women. *Journal of Women’s Health*. 2021;30(7):927-934. doi: 10.1089/jwh.2020.8380
	Nugent BM, Madabushi R, Buch B, Peiris V, Crentsil V, Miller VM, Bull J, Jenkins MR. Heterogeneity in treatment effects across diverse populations. *Pharmaceutical Statistics*. 2021;20(5):929-938. doi:10.1002/pst.2161
	South EM, Zinn RL, Huang CJ, Vasisht KP. US Food and Drug Administration Office of Women’s Health: Promoting Therapeutic Optimization in women. *The Journal of Clinical Pharmacology*. 2020;60(S2). doi:10.1002/jcph.1712
	Ross JS, Rohde S, Sangaralingham L, Brito JP, Choi L, Dutcher SK, Graham DJ, Jenkins MR, Lipska KJ, Mendoza M, Qiang Y, Wang Z, Wu Y, Yao X, Shah ND. Generic and Brand-Name Thyroid Hormone Drug Use Among Commercially Insured and Medicare Beneficiaries, 2007 Through 2016. *J Clin Endo Metab*. 2019;104:2305-2314. doi: 10.1210/jc.2018-02197
	Ayuso E, Geller RJ, Wang J, Whyte J, Jenkins M. Evaluation of Worldwide Clinical Trials by Gender: an FDA Perspective. *Contemporary Clinical Trials*. 2019; 80:16-21. doi: 10.1016/j.cct.2019.03.007
	Scott P, Unger E, Jenkins M, Southworth MR, McDowell T, Geller RJ, Elahi M, Temple RJ, Woodcock J. Participation of Women in Clinical Trials Supporting FDA Approval of Cardiovascular Drugs. *Journal of the American College of Cardiology*.  2018; 71:1960-1969. doi: 10.1016/j.jacc.2018.02.0702016


2012 - 2016
	*Journal (full paper):*

Elahi M, Eshera N, Bambata N, Barr H, Lyn-Cook B, Beitz J, Rios M, Taylor DR, Lightfoote M, Hanafi N, DeJager L. The Food and Drug Administration Office of Women’s Health: Impact of Science on Regulatory Policy: An Update. *Journal of Women's Health*. 2016;25(3)222-34 doi:10.1089/jwh.2015.5671.
	Hansen CD, Andrade SE, Freiman H, Dublin S, Haffenreffer K, Cooper WO, Cheetham TC, Toh S, Li D, Raebel MA, Kuntz JL, Perrin N, Rosales AG, Carter S, Pawloski PA, Maloney EM, Graham DJ, Sahin L, Scott PE, Yap J, Davis R. Trimethoprim-sulfonamide use during the first trimester of pregnancy and the risk of congenital anomalies. Pharmacoepidemiology and Drug Safety. 2015;25(2):170-178. doi:10.1002/pds.3919
	Struble EB, Fadiran EO, Soule L. Thrombosis during pregnancy: Risks, prevention, and treatment for mother and fetus. *Birth Defects Research*. 2015;105(3):157-158. doi:10.1002/bdrc.21110
	Eshera N, Itana H, Zhang L, Soon G, Fadiran EO. Demographics of clinical trials Participants in pivotal clinical trials for new molecular entity drugs and biologics approved by FDA from 2010 to 2012. *American Journal of Therapeutics*. 2015;22(6):435-455. doi:10.1097/mjt.0000000000000177*Book Chapter:*

Fadiran EO, Zhang L. Effects of sex differences in the pharmacokinetics of drugs and their impact on the safety of medicines in women. *In Medicines for Women* 2014 (pp. 41-68). Cham: Springer International Publishing.*Journal (full paper):*

Poon R, Khanijow K, Umarjee S, Fadiran E, Yu M, Zhang L, Parekh A. Participation of women and sex analyses in Late-Phase clinical trials of new molecular entity drugs and biologics approved by the FDA in 2007–2009. *Journal of Womens Health*. 2013;22(7):604-616. doi:10.1089/jwh.2012.3753
	Hess CN, Rao SV, Kong DF, Miller JM, Anstrom KJ, Bertrand OF, Collet J, Effron MB, Eloff BC, Fadiran EO, Farb A, Gilchrist IC, Holmes DR, Jacobs AK, Kaul P, Newby LK, Rutledge DR, Tavris DR, Tsai TT, White RM, Krucoff MW. TransRadial Education and Therapeutics (TREAT): Shifting the balance of safety and efficacy of antithrombotic agents in percutaneous coronary intervention. *American Heart Journal*. 2013;165(3):344-353.e1. doi:10.1016/j.ahj.2012.09.008
	Tavris DR, Wang Y, Jacobs S, Gallauresi B, Curtis J, Messenger J, Resnic FS, Fitzgerald S. Bleeding and vascular complications at the femoral access site following percutaneous coronary intervention (PCI): an evaluation of hemostasis strategies. *J Invasive Cardiol*. 2012;24(7):328-334. PMID: 22781471.
	Coakley MF, Fadiran EO, Parrish LJ, Griffith RA, Weiss E, Carter C. Dialogues on Diversifying Clinical Trials: Successful Strategies for Engaging Women and Minorities in Clinical Trials. *Journal of Womens Health*. 2012;21(7):713-716. doi:10.1089/jwh.2012.3733


2006 - 2011
	*Book Chapter:*

Parekh A. Women in Clinical Drug Trials: United States Food and Drug Administration Update on Policies and Practices. Schenck-Gustafsson K, DeCola PR, Pfaff DW, Pisetsky DS. *Handbook of Clinical Gender Medicine*. Karger 2012. https://doi.org/10.1159/000336443
	Tavris D, Gallauresi B. Chapter: **Hemostasis Devices*** Book: Coronary Interventions*Journal (full paper):*

Florian JA, Tornøe CW, Brundage R, Parekh A, Garnett CE. Population Pharmacokinetic and Concentration—QTc Models for Moxifloxacin: Pooled Analysis of 20 Thorough QT Studies. The Journal of Clinical Pharmacology. 2013; 51: 1152-1162. doi: 10.1177/0091270010381498
	Haas D, Gallauresi B, Shields K, Zeitlin D, Clark S, Hebert M, Ren Z, Nallani S, Meslin E, Feibus K, Koren G, Goebel WS, Easterling T, Denne SC, Flockhart DA, Renbarger JL. Pharmacotherapy and pregnancy: highlights from the Third International Conference for Individualized Pharmacotherapy in Pregnancy. *Clinical and Translation Science*. 2011;4(3):204-209. doi:10.1111/j.1752-8062.2011.00280.x
	Parekh A, Fadiran EO, Uhl K, Throckmorton DC. Adverse Effects in Women: Implications for Drug Development and Regulatory Policies. *Expert Reviews Clinical Pharmacology*. 2011; 4(4):453-466 doi: 10.1586/ecp.11.29
	Goldkind S, Sahin L, Gallauresi B. Enrolling Pregnant Women in Research — Lessons from the H1N1 Influenza Pandemic. *The New England Journal of Medicine*. 2010; 362:2241-43 doi: 10.1056/NEJMp1003462*Book Chapter:*

Fleisher D, Sweet B, Parekh A. Chapter: Drug Absorption with Food. Section: Influence of Food or Nutrients on Drug Disposition and Effect. Text: Handbook of Drug-Nutrient Interactions, 2nd Edition 2009*Journal (full paper):*

Finkle J, Bloomfield D, Uhl K, Sanhai W, Stockbridge N, Krucoff MW. New precompetitive paradigms: focus on cardiac safety. *Cardiac Safety Research Consortium Conference Papers*. 2009;157(5):825-826. doi:10.1016/j.ahj.2009.02.021
	Pinnow E, Sharma P, Parekh A, Gevorkian N, Uhl K. Increasing participation of women in early phase clinical trials approved by the FDA. *Womens Health Issues*. 2009;19(2):89-93. doi:10.1016/j.whi.2008.09.009
	Wisner KL, Appelbaum PS, Uhl, K, Goldkind, SF. Pharmacotherapy for Depressed Pregnant Women: Overcoming Obstacles to Gathering Essential Data. *Clinical Pharmacology & Therapeutics*. 2009;86: 362-365. doi: 10.1038/clpt.2009.160
	Presented at ASCPT 2009 annual meeting
	Sharma P, Parekh A, Uhl K. An innovative approach to determine fetal risk: the FDA Office of Women's Health pregnancy exposure registry web listing. *Womens Health Issues*. 2008;18(4):226-228. doi:10.1016/j.whi.2008.02.006
	Oliva A, Pinnow E, Levin R, Uhl K. Improving women's health through modernization of our bioinformatics infrastructure. *Clinical Pharmacology & Therapeutics*. 2008;83(1):192-195. doi:10.1038/sj.clpt.6100437
	Andrade S, Raebel M, Brown J, Lane K, Livingston J, Boudreau D, Rolnick S, Roblin D, Smith D,  Dal Pan GJ, Scott P, Platt R. Outpatient use of cardiovascular drugs during pregnancy. *Pharmacoepidemiology and Drug Safety*. 2008;17(3):240-247. doi:10.1002/pds.1550
	Obias-Manno D, Scott P, Kaczmarczyk J, Miller M, Pinnow E, Lee-Bishop L, Jones-London M, Chapman K, Kallgren D, Uhl K. The Food and Drug Administration Office of Women's Health: impact of science on regulatory policy. *Journal of Women's Health*. 2007;16(6):807-817. doi:10.1089/jwh.2006.0135
	Parekh A, Sanhai W, Marts S, Uhl K. Advancing women's health via FDA Critical Path Initiative. *Drug Discov Today Technol*. 2007;4(2):69-73. doi:10.1016/j.ddtec.2007.10.014
	Uhl K, Parekh A, Kweder S. Females in clinical studies: where are we going? *Clin Pharmacol Ther*. 2007;81(4):600-602. doi:10.1038/sj.clpt.6100112


1994 - 2005
	*Book Chapter:*

SM Huang, M Miller, T Toigo, M Chen, C Sahajwalla, L Lesko, R Temple. Evaluation of Drugs in Women: Regulatory Perspective. Section 11, Drug Metabolism/Clinical Pharmacology (Section editor: Schwartz, J.; Legato, M (ed)) Principles of Gender-Specific Medicine, pp 848-859, Academic Press, 2004*Journal (full paper):*

Wood SF. Women's health and the FDA. N Engl J Med. 2005;353(16):1650-1651. doi:10.1056/NEJMp058225
	Evelyn B, Toigo T, Banks D, Pohl D, Gray K, Robins B, Ernat J. Participation of racial/ethnic groups in clinical trials and race-related labeling: a review of new molecular entities approved 1995-1999. *J Natl Med Assoc*. 2001;93(12 Suppl):18S-24S.
	Miller MA. Gender-based differences in the toxicity of pharmaceuticals--the Food and Drug Administration's perspective. *International Journal of Toxicology*. 2001;20(3):149-152. doi:10.1080/109158101317097728
	Toigo T. Hearing the cry for help and information. *FDA Consumer 2001*, p36
	Wood SF. Office of Women's Health, Food and Drug Administration: future directions for women's health. *J Am Med Womens Assoc (1972)*. 2001;56(4):197-198.
	Martinez M, Friedlander L, Condon R, et al. Response to criticisms of the US FDA parametric approach for withdrawal time estimation: rebuttal and comparison to the nonparametric method proposed by Concordet and Toutain. *Journal of Veterinary Pharmacology and Therapeutics*. 2000;23(1):21-35. doi:10.1046/j.1365-2885.2000.00242.x
	Poirier LA, Doerge DR, Gaylor DW, Miller MA, Lorentzen RJ, Casciano DA, Kadlubar FF, Schwetz BA. An FDA review of sulfamethazine toxicity. *Regulatory Toxicology and Pharmacology*. 1999;30(3):217-222. doi:10.1006/rtph.1999.1348
	Sherman LA, Temple R, Merkatz RB. Women in clinical trials: an FDA perspective. *Science*. 1995;269(5225):793-795. doi:10.1126/science.7638593
	Merkatz RB, Summers EI, Toigo TA. FDA: making a difference for women and HIV/AIDS. *J Am Med Womens Assoc (1972)*. 1995;50(3-4):108-120.
	Merkatz R. FDA: making a difference in women's health. *J Am Med Womens Assoc (1972*). 1994;49(4):117-121.
	Merkatz RB, Junod SW. Historical background of changes in FDA policy on the study and evaluation of drugs in women. *Academic Medicine*. 1994;69(9):703-707. doi:10.1097/00001888-199409000-00004


**Related links**

FDA research portal
	Free publications for women– easy-to read publications on a variety of health topics
	Basic Science and the Biological Basis for Sex- and Gender-Related Differences (NIH training courses)

                                                                                  Content current as of:
      12/19/2023OWH-funded research

          
                        Extramural research
          Intramural research
          Project areas by topic
          Peer-reviewed scientific publications (by OWH staff)
 
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