Increasing Participation of Women in Early Phase Clinical Trials Approved by the FDA

References 

1. Back DJ, Orme ML. Pharmacokinetic drug interactions with oral contraceptives. Clinical Pharmacokinetics. 1990;8:472–484
2. Evelyn, B., Toigo, T., Banks, D., Pohl, D., Gray, K., Robins, B., et al. (2001). Women's participation in clinical trials and a gender-related labeling: A review of New molecular entities approved 1995–1999. Available: http://www.fda.gov/cder/reports/womens_health/women_clin_trials.htm. Accessed February 29, 2008.
3. Food and Drug Administration (FDA). (1977) . General considerations for the clinical evaluation of drugs. HEW Publication No. (FDA) 77-3040. Available: http://www.fda.gov/CDER/GUIDANCE/old034fn.pdfAccessed February 29, 2008
4. Food and Drug Administration (FDA). (1993). Study and evaluation of gender differences in the clinical evaluation of drugs. Available: http://www.fda.gov/cder/guidance/old036fn.pdf. Accessed February 29, 2008.
5. Food and Drug Administration (FDA). (1998). Center for Drug Evaluation and Research. The CDER Handbook. Available: http://www.fda.gov/cder/handbook/phase1.htm. Accessed February 29, 2008.
6. Food and Drug Administration (FDA). (2004). Manual of policies and procedures. Thalidomide as a teratogen. Center for Drug Evaluation and Research MaPP 6010.3. Available: http://www.fda.gov/cder/mapp/6010.3.pdf. Accessed February 29, 2008.
7. Government Accountability Office (GAO). (1992). Women's health: FDA needs to ensure more study of gender differences in prescription drug testing, HRD-93–17. Available: http://archive.gao.gov/d35t11/147861.pdf. Accessed February 29, 2008.
8. Government Accountability Office (GAO). (2001a). Drugs withdrawn from market. Drug safety: Most drugs withdrawn in recent years had greater health risks for women. GAO-01-286R, 2001. Available: http://www.gao.gov/new.items/d01286r.pdf. Accessed February 29, 2008.
9. Government Accountability Office (GAO). (2001b). Women's health: Women sufficiently represented in new drug testing, but FDA oversight needs improvement. Available: at http://www.gao.gov/new.items/d01754.pdf. Accessed February 29, 2008.
10. Government Accountability Office (GAO). (2006). New drug development: Science, business, regulatory, and intellectual property issues cited as hampering drug development efforts. Available: http://www.gao.gov/new.items/d0749.pdf. Accessed February 29, 2008.
11. Thalidomide as a teratogen. In:  Gilbert SF editors. Developmental biology. Sunderland, MA: Elsevier; 2006;p. 667–675
12. Harris RZ, Benet LZ, Schwartz JB. Gender effects in pharmacokinetics and pharmacodynamics. Drugs. 1995;50:222–239
    • MEDLINE
    • CrossRef
13. Miller MA. Gender-based differences in the toxicity of pharmaceuticals—The Food and Drug Administration's perspective. International Journal of Toxicology. 2001;20:149
    • MEDLINE
    • CrossRef
14. Rademaker M. Do women have more adverse drug reactions?. American Journal of Clinical Dermatology. 2001;2:349–351
    • MEDLINE
    • CrossRef
15. Sherman LA, Temple R, Merkatz RB. Women in clinical trials: An FDA perspective. Science. 1995;269:793
    • MEDLINE
16. Thurmann PA, Hompesch BC. Influence of gender on the pharmacokinetics and pharmacodynamics of drugs. International Journal of Clinical Pharmacology and Therapeutics. 1998;36:586–590
    • MEDLINE
17. In:  Wizemann TM,  Pardue M-L editor. Exploring the biological contributions to human health: Does sex matter?. Washington, DC: National Academy Press; 2001;p. 117–172
18. Yang, Y., Carlin, A., Faustino, P., Pagán-Motta, P., Hamad, M., He, R., et al. (n.d. In press). Participation of women in clinical trials for new drugs approved by the Food and Drug Administration between 2000–2002. Unpublished data accepted for publication in the Journal of women's health.