메뉴 건너뛰기




Volumn 16, Issue 6, 2007, Pages 807-817

The Food and Drug Administration Office of Women's Health: Impact of science on regulatory policy

Author keywords

[No Author keywords available]

Indexed keywords

DIET SUPPLEMENTATION; FOOD AND DRUG ADMINISTRATION; FUNDING; HEALTH CARE POLICY; HEALTH PROGRAM; HUMAN; PRIORITY JOURNAL; QT PROLONGATION; RESEARCH PRIORITY; REVIEW; SCIENCE; WOMEN'S HEALTH;

EID: 34547948551     PISSN: 15409996     EISSN: None     Source Type: Journal    
DOI: 10.1089/jwh.2006.0135     Document Type: Review
Times cited : (17)

References (81)
  • 1
    • 34547954821 scopus 로고    scopus 로고
    • Senate report 103-102 July 20, 1993.
    • Senate report 103-102 July 20, 1993.
  • 2
    • 34547950008 scopus 로고    scopus 로고
    • Available at Accessed October 22, 2006
    • Update on women and family issues in Congress. Available at www.mith2.umd.edu/WomensStudies/GovernmentPolitics/CaucusUpdates/ Update-vol14no4/headlines Accessed October 22, 2006.
    • Update on women and family issues in Congress
  • 3
    • 34547961772 scopus 로고    scopus 로고
    • Federal Register. Department of Health and Human Services Notice GN #2260. 1994, July 28;59:144.
    • Federal Register. Department of Health and Human Services Notice GN #2260. 1994, July 28;59:144.
  • 4
    • 34547932488 scopus 로고    scopus 로고
    • Available at: Accessed October 25, 2006
    • Ten years and Beyond. Available at: www.fda.gov/womens/reports/ report0306.pdf Accessed October 25, 2006.
    • Ten years and Beyond
  • 5
    • 34547936788 scopus 로고    scopus 로고
    • U.S. Food and Drug Administration: available at Accessed October 25
    • U.S. Food and Drug Administration: OWH Science Program available at www.fda.gov/womens/science.html Accessed October 25, 2006.
    • (2006) OWH Science Program
  • 7
    • 0242380326 scopus 로고    scopus 로고
    • Women's health and clinical trials
    • Schiebinger L. Women's health and clinical trials J Clin Invest 2003;112:973.
    • (2003) J Clin Invest , vol.112 , pp. 973
    • Schiebinger, L.1
  • 8
    • 0034932889 scopus 로고    scopus 로고
    • Gender-based differences in the toxicity of pharmaceuticals - The Food and Drug Administration's perspective
    • Miller MA. Gender-based differences in the toxicity of pharmaceuticals - The Food and Drug Administration's perspective. Int J Toxicol 2001;20:149.
    • (2001) Int J Toxicol , vol.20 , pp. 149
    • Miller, M.A.1
  • 9
    • 0027198952 scopus 로고
    • Women in clinical trials of new drugs. A change in Food and Drug Administration policy. The Working Group on Women in Clinical Trials
    • Merkatz RB, Temple R, Subel S, Feiden K, Kessler DA. Women in clinical trials of new drugs. A change in Food and Drug Administration policy. The Working Group on Women in Clinical Trials. N Engl J Med 1993;329:292.
    • (1993) N Engl J Med , vol.329 , pp. 292
    • Merkatz, R.B.1    Temple, R.2    Subel, S.3    Feiden, K.4    Kessler, D.A.5
  • 10
    • 0028033394 scopus 로고
    • Historical background of changes in FDA policy on the study and evaluation of drugs in women
    • Merkatz RB, Junod SW. Historical background of changes in FDA policy on the study and evaluation of drugs in women. Acad Med 1994;69:703.
    • (1994) Acad Med , vol.69 , pp. 703
    • Merkatz, R.B.1    Junod, S.W.2
  • 14
    • 34547959071 scopus 로고    scopus 로고
    • Gender studies in product development: Available at Accessed October 14, 2006
    • Gender studies in product development: Scientific Issues and Approaches, November 1995. Available at www.fda.gov/womens/gender.html Accessed October 14, 2006.
    • Scientific Issues and Approaches, November 1995
  • 15
    • 34547943544 scopus 로고    scopus 로고
    • The Office of Women's Health scientific research program: Abstracts
    • U.S. Food and Drug Administration, trials. Available at Accessed April 26
    • U.S. Food and Drug Administration. The Office of Women's Health scientific research program: Abstracts. Development and expansion of a pilot tracking system for monitoring the barriers to the enrollment of women in clinical trials. Available at www.fda.gov/womens/scienceprogram/report2000/ abstracts.htm#womenclinical Accessed April 26, 2006.
    • (2006) Development and expansion of a pilot tracking system for monitoring the barriers to the enrollment of women in clinical
  • 16
    • 84902056013 scopus 로고    scopus 로고
    • Evaluation of drugs in women: Regulatory perspective
    • Legato M, ed, New York: Elsevier Academic Press
    • Huang S-M, Miller M, Toigo T, et al. Evaluation of drugs in women: Regulatory perspective. In: Legato M, ed. Principles of gender-specific medicine. New York: Elsevier Academic Press, 2004:848.
    • (2004) Principles of gender-specific medicine , pp. 848
    • Huang, S.-M.1    Miller, M.2    Toigo, T.3
  • 17
    • 34547959628 scopus 로고    scopus 로고
    • The Medical Device Amendments of 1976 to the Federal Food, Drug, and Cosmetic Act. 21 CFR 812.
    • The Medical Device Amendments of 1976 to the Federal Food, Drug, and Cosmetic Act. 21 CFR 812.
  • 18
    • 34547934713 scopus 로고    scopus 로고
    • FDA Consumer Magazine. September-October 2004. Making an informed decision about breast implants Available at www.fda.gov/fdac/features/2004/ 504_implants.html
    • FDA Consumer Magazine. September-October 2004. Making an informed decision about breast implants Available at www.fda.gov/fdac/features/2004/ 504_implants.html
  • 19
    • 0031147996 scopus 로고    scopus 로고
    • Characterization of cellular response to silicone implants in rats: Implications for foreign body carcinogenesis
    • James SJ, Pogribna M, Miller BJ, Bolon B, Muskhelishvili L. Characterization of cellular response to silicone implants in rats: Implications for foreign body carcinogenesis. Biomaterials 1997;18:667.
    • (1997) Biomaterials , vol.18 , pp. 667
    • James, S.J.1    Pogribna, M.2    Miller, B.J.3    Bolon, B.4    Muskhelishvili, L.5
  • 20
    • 0345552209 scopus 로고    scopus 로고
    • Silicone gel-filled breast and testicular implant capsules: A histologic and immunophenotypic study
    • Abbondanzo SL, Young VL, Wei MQ, Miller FW. Silicone gel-filled breast and testicular implant capsules: A histologic and immunophenotypic study. Mod Pathol 1999;12:706.
    • (1999) Mod Pathol , vol.12 , pp. 706
    • Abbondanzo, S.L.1    Young, V.L.2    Wei, M.Q.3    Miller, F.W.4
  • 21
    • 0033863572 scopus 로고    scopus 로고
    • Restricted and shared patterns of TCR beta-chain gene expression in silicone breast implant capsules and remote sites of tissue inflammation
    • O'Hanlon TP, Lawless OJ, Katzin WE, Feng LJ, Miller FW. Restricted and shared patterns of TCR beta-chain gene expression in silicone breast implant capsules and remote sites of tissue inflammation. J Autoimmun 2000;14:283.
    • (2000) J Autoimmun , vol.14 , pp. 283
    • O'Hanlon, T.P.1    Lawless, O.J.2    Katzin, W.E.3    Feng, L.J.4    Miller, F.W.5
  • 22
    • 0033796965 scopus 로고    scopus 로고
    • Prevalence of rupture of silicone gel breast implants revealed on MR imaging in a population of women in Birmingham, Alabama
    • Brown SL, Middleton MS, Berg WA, Soo MS, Pennello G. Prevalence of rupture of silicone gel breast implants revealed on MR imaging in a population of women in Birmingham, Alabama. Am J Roentgenol 2000;175:1057.
    • (2000) Am J Roentgenol , vol.175 , pp. 1057
    • Brown, S.L.1    Middleton, M.S.2    Berg, W.A.3    Soo, M.S.4    Pennello, G.5
  • 23
    • 0035003092 scopus 로고    scopus 로고
    • Silicone gel breast implant rupture, extracapsular silicone, and health status in a population of women
    • Brown SL, Pennello G, Berg WA, Soo MS, Middleton MS. Silicone gel breast implant rupture, extracapsular silicone, and health status in a population of women. J Rheumatol 2001;28:996.
    • (2001) J Rheumatol , vol.28 , pp. 996
    • Brown, S.L.1    Pennello, G.2    Berg, W.A.3    Soo, M.S.4    Middleton, M.S.5
  • 24
    • 0036245940 scopus 로고    scopus 로고
    • Replacement surgery and silicone gel breast implant rupture: Self-report by women after mammoplasty
    • Brown SL, Pennello G. Replacement surgery and silicone gel breast implant rupture: Self-report by women after mammoplasty. J Womens Health Gend Based Med 2002;11:255.
    • (2002) J Womens Health Gend Based Med , vol.11 , pp. 255
    • Brown, S.L.1    Pennello, G.2
  • 26
    • 34547946799 scopus 로고    scopus 로고
    • The Office of Women's Health Scientific Program: Appendix I
    • U.S. Food and Drug Administration, trials. Available at Accessed October 14
    • U.S. Food and Drug Administration. The Office of Women's Health Scientific Program: Appendix I. Women in clinical trials. Available at www.fda.gov/womens/scienceprogram/report2000/appendix.htm Accessed October 14, 2006.
    • (2006) Women in clinical
  • 27
    • 14644412444 scopus 로고    scopus 로고
    • Predicting drug-hERG channel interactions that cause acquired long QT syndrome
    • Sanguinetti MC, Mitcheson JS. Predicting drug-hERG channel interactions that cause acquired long QT syndrome. Trends Pharmacol Sci 2005;26:119.
    • (2005) Trends Pharmacol Sci , vol.26 , pp. 119
    • Sanguinetti, M.C.1    Mitcheson, J.S.2
  • 28
    • 0033404894 scopus 로고    scopus 로고
    • The QT interval and torsade de pointes
    • Moss AJ. The QT interval and torsade de pointes. Drug Saf 1999;21(Suppl 1):5.
    • (1999) Drug Saf , vol.21 , Issue.SUPPL. 1 , pp. 5
    • Moss, A.J.1
  • 29
    • 0036847968 scopus 로고    scopus 로고
    • Sex differences in QTc interval and QT dispersion: Dynamics during exercise and recovery in healthy subjects
    • Chauhan VS, Krahn AD, Walker BD, Kelin GJ, Skanes AC, Yee R. Sex differences in QTc interval and QT dispersion: Dynamics during exercise and recovery in healthy subjects. Am Heart J 2002;144:858.
    • (2002) Am Heart J , vol.144 , pp. 858
    • Chauhan, V.S.1    Krahn, A.D.2    Walker, B.D.3    Kelin, G.J.4    Skanes, A.C.5    Yee, R.6
  • 30
    • 0026786140 scopus 로고
    • Sex differences in the evolution of the electrocardiographic QT interval with age
    • Rautaharju PM, Zhou SH, Wong S, et al. Sex differences in the evolution of the electrocardiographic QT interval with age. Can J Cardiol 1992;8:690.
    • (1992) Can J Cardiol , vol.8 , pp. 690
    • Rautaharju, P.M.1    Zhou, S.H.2    Wong, S.3
  • 33
    • 34547956552 scopus 로고    scopus 로고
    • Available at Accessed October 25, 2006
    • Data mining AERS. Available at www.fda.gov/ohrms/dockets/ac/05/slides/ 2005-4143S1_07_McCloskey.ppt Accessed October 25, 2006.
    • Data mining, A.E.R.S.1
  • 34
    • 0036300732 scopus 로고    scopus 로고
    • Use of screening algorithms and computer systems to efficiently signal higher-than-expected combinations of drugs and events in the US FDA's spontaneous reports database
    • Szarfman A, Machado SG, O'Neill RT Use of screening algorithms and computer systems to efficiently signal higher-than-expected combinations of drugs and events in the US FDA's spontaneous reports database. Drug Saf 2002;25:381.
    • (2002) Drug Saf , vol.25 , pp. 381
    • Szarfman, A.1    Machado, S.G.2    O'Neill, R.T.3
  • 35
    • 0042413852 scopus 로고    scopus 로고
    • Disproportionality analysis using empirical Bayes data mining: A tool for the evaluation of drug interactions in the post-marketing setting
    • Almenoff JS, DuMouchel W, Kindman LA, Yang X, Fram D. Disproportionality analysis using empirical Bayes data mining: A tool for the evaluation of drug interactions in the post-marketing setting. Pharmacoepidemiol Drug Saf 2003;12:517.
    • (2003) Pharmacoepidemiol Drug Saf , vol.12 , pp. 517
    • Almenoff, J.S.1    DuMouchel, W.2    Kindman, L.A.3    Yang, X.4    Fram, D.5
  • 36
    • 34547959267 scopus 로고    scopus 로고
    • Poster abstracts. Gender-related "higher-than-expected" drug-event combinations in spontaneous adverse drug event reports, CDER
    • U.S. Food and Drug Administration, Available at Accessed April 26
    • U.S. Food and Drug Administration. Poster abstracts. Gender-related "higher-than-expected" drug-event combinations in spontaneous adverse drug event reports, CDER, FDA 2000 FDA Science Forum. Available at vm.cfsan.fda.gov/~frf/forum00/abst00ct.htm Accessed April 26, 2006.
    • (2006) FDA 2000 FDA Science Forum
  • 37
    • 27744580767 scopus 로고    scopus 로고
    • Drug-induced proarrhythmia and use of QTc-prolonging agents: Clues for clinicians
    • Heist EK, Ruskin JN. Drug-induced proarrhythmia and use of QTc-prolonging agents: Clues for clinicians. Heart Rhythm 2005;2(Suppl 2):S1.
    • (2005) Heart Rhythm , vol.2 , Issue.SUPPL. 2
    • Heist, E.K.1    Ruskin, J.N.2
  • 38
    • 0034967764 scopus 로고    scopus 로고
    • Postmarketing reports of QT prolongation and ventricular arrhythmia in association with cisapride and Food and Drug Administration regulatory actions
    • Wysowski DK, Corken A, Gallo-Torres H, Talarico L, Rodriguez EM. Postmarketing reports of QT prolongation and ventricular arrhythmia in association with cisapride and Food and Drug Administration regulatory actions. Am J Gastroenterol 2001;96:1698.
    • (2001) Am J Gastroenterol , vol.96 , pp. 1698
    • Wysowski, D.K.1    Corken, A.2    Gallo-Torres, H.3    Talarico, L.4    Rodriguez, E.M.5
  • 39
    • 22144474788 scopus 로고    scopus 로고
    • Adverse drug event surveillance and drug withdrawals in the United States, 1969-2002: The importance of reporting suspected reactions
    • Wysowski DK, Swartz L. Adverse drug event surveillance and drug withdrawals in the United States, 1969-2002: The importance of reporting suspected reactions. Arch Intern Med 2005;165:1363.
    • (2005) Arch Intern Med , vol.165 , pp. 1363
    • Wysowski, D.K.1    Swartz, L.2
  • 40
    • 27744471093 scopus 로고    scopus 로고
    • Drug-induced torsades de pointes: The evolving role of pharmacogenetics
    • Fitzgerald PT, Ackerman MJ. Drug-induced torsades de pointes: The evolving role of pharmacogenetics. Heart Rhythm 2005;2(Suppl 2):S30.
    • (2005) Heart Rhythm , vol.2 , Issue.SUPPL. 2
    • Fitzgerald, P.T.1    Ackerman, M.J.2
  • 41
    • 34547946467 scopus 로고    scopus 로고
    • U.S. General Accounting Office. Drugs withdrawn from market. Drug safety: Most drugs withdrawn in recent years had greater health risks for women. GAO-01-286R, 2001. Available at www.gao.gov/new. items/d01286r.pdf Accessed April 25, 2006.
    • U.S. General Accounting Office. Drugs withdrawn from market. Drug safety: Most drugs withdrawn in recent years had greater health risks for women. GAO-01-286R, 2001. Available at www.gao.gov/new. items/d01286r.pdf Accessed April 25, 2006.
  • 43
    • 33746796124 scopus 로고    scopus 로고
    • U.S. Food and Drug Administration, Droperidol, Available at Accessed April 27
    • U.S. Food and Drug Administration. Important drug warning: Inapsine (Droperidol). Available at www.fda.gov/medwatch/SAFETY/2001/inapsine.htm Accessed April 27, 2006.
    • (2006) Important drug warning: Inapsine
  • 44
    • 34547947319 scopus 로고    scopus 로고
    • U.S. Food and Drug Administration, professional Fluothane, Available at Accessed April 27
    • U.S. Food and Drug Administration. Dear healthcare professional (Fluothane), 2000. Available at www.fda. gov/medwatch/safety/2000/fluoth. htm Accessed April 27, 2006.
    • (2000) Dear healthcare
  • 45
    • 0035985144 scopus 로고    scopus 로고
    • Drug-induced prolongation of the QT interval: Regulatory dilemmas and implications for approval and labeling of a new chemical entity
    • Shah RR. Drug-induced prolongation of the QT interval: Regulatory dilemmas and implications for approval and labeling of a new chemical entity. Fundam Clin Pharmacol 2002;16:147.
    • (2002) Fundam Clin Pharmacol , vol.16 , pp. 147
    • Shah, R.R.1
  • 46
    • 84889869638 scopus 로고    scopus 로고
    • Safety pharmacologic studies for assessing the potential for delayed ventricular repolarization (Qt interval prolongation by human pharmaceuticals)
    • U.S. Food and Drug Administration, Available at Accessed April 25
    • U.S. Food and Drug Administration. Safety pharmacologic studies for assessing the potential for delayed ventricular repolarization (Qt interval prolongation by human pharmaceuticals). ICH draft S7B, 2002. Available at www.fda.gov/ohrms/dockets/98fr/02d-0232-gdl0001-vol1.PDF Accessed April 25, 2006.
    • (2002) ICH draft
  • 47
    • 33644782827 scopus 로고    scopus 로고
    • Comparative evaluation of HERG currents and QT intervals following challenge with suspected torsadogenic and non-torsadogenic drugs
    • Katchman AN, Koerner J, Tosaka T, Woosley RL, Ebert SN. Comparative evaluation of HERG currents and QT intervals following challenge with suspected torsadogenic and non-torsadogenic drugs. J Pharmacol Exp Ther 2005;316:1098.
    • (2005) J Pharmacol Exp Ther , vol.316 , pp. 1098
    • Katchman, A.N.1    Koerner, J.2    Tosaka, T.3    Woosley, R.L.4    Ebert, S.N.5
  • 48
    • 0344492207 scopus 로고    scopus 로고
    • Relationships between preclinical cardiac electrophysiology, clinicalQT interval prolongation and torsade de pointes for a broad range of drugs: Evidence for a provisional safety margin in drug development
    • Redfern WS, Carlsson L, Davis AS, et al. Relationships between preclinical cardiac electrophysiology, clinicalQT interval prolongation and torsade de pointes for a broad range of drugs: Evidence for a provisional safety margin in drug development. Cardiovasc Res 2003;58:32.
    • (2003) Cardiovasc Res , vol.58 , pp. 32
    • Redfern, W.S.1    Carlsson, L.2    Davis, A.S.3
  • 49
    • 3042528658 scopus 로고    scopus 로고
    • Mechanisms of arsenic-induced prolongation of cardiac repolarization
    • Ficker E, Kuryshev YA, Dennis AT, et al. Mechanisms of arsenic-induced prolongation of cardiac repolarization. Mol Pharmacol 2004;66:33.
    • (2004) Mol Pharmacol , vol.66 , pp. 33
    • Ficker, E.1    Kuryshev, Y.A.2    Dennis, A.T.3
  • 50
    • 0036741257 scopus 로고    scopus 로고
    • T wave alternans and torsades de pointes after the use of intravenous pentamidine
    • Kroll CR, Gettes LS. T wave alternans and torsades de pointes after the use of intravenous pentamidine. J Cardiovasc Electrophysiol 2002;13:936.
    • (2002) J Cardiovasc Electrophysiol , vol.13 , pp. 936
    • Kroll, C.R.1    Gettes, L.S.2
  • 52
    • 27144485834 scopus 로고    scopus 로고
    • Gender and its effect in cardiovascular pharmacotherapeutics: Recent considerations
    • Sica DA, Wood M, Hess M. Gender and its effect in cardiovascular pharmacotherapeutics: Recent considerations. Congest Heart Fail 2005;11:163.
    • (2005) Congest Heart Fail , vol.11 , pp. 163
    • Sica, D.A.1    Wood, M.2    Hess, M.3
  • 53
    • 0028596404 scopus 로고
    • Gender differences in human pharmacokinetics and pharmacodynamics
    • Fletcher CV, Acosta EP, Strykowski JM. Gender differences in human pharmacokinetics and pharmacodynamics. J Adolesc Health 1994;15:619.
    • (1994) J Adolesc Health , vol.15 , pp. 619
    • Fletcher, C.V.1    Acosta, E.P.2    Strykowski, J.M.3
  • 54
    • 0036290013 scopus 로고    scopus 로고
    • How important are gender differences in pharmacokinetics?
    • Meibohm B, Beierle I, Derendorf H. How important are gender differences in pharmacokinetics? Clin Pharmacokinet 2002;41:329.
    • (2002) Clin Pharmacokinet , vol.41 , pp. 329
    • Meibohm, B.1    Beierle, I.2    Derendorf, H.3
  • 55
    • 25844507083 scopus 로고    scopus 로고
    • Confounding factors for sex differences in pharmacokinetics and pharmacodynamics: Focus on dosing regimen, dosage form, and formulation
    • Chen ML. Confounding factors for sex differences in pharmacokinetics and pharmacodynamics: focus on dosing regimen, dosage form, and formulation. Clin Pharmacol Ther 2005;78:322.
    • (2005) Clin Pharmacol Ther , vol.78 , pp. 322
    • Chen, M.L.1
  • 56
    • 25144516296 scopus 로고    scopus 로고
    • Pregnancy-induced changes in pharmacokinetics: A mechanistic-based approach
    • Anderson GD. Pregnancy-induced changes in pharmacokinetics: A mechanistic-based approach. Clin Pharmacokinet 2005;44:989.
    • (2005) Clin Pharmacokinet , vol.44 , pp. 989
    • Anderson, G.D.1
  • 57
    • 4644292725 scopus 로고    scopus 로고
    • Complex clinical, legal, and ethical issues of pregnant and postpartum women as subjects in clinical trials
    • Uhl K, Miller MA, Kennedy DL. Complex clinical, legal, and ethical issues of pregnant and postpartum women as subjects in clinical trials. J Womens Health 2004;13:743.
    • (2004) J Womens Health , vol.13 , pp. 743
    • Uhl, K.1    Miller, M.A.2    Kennedy, D.L.3
  • 58
    • 34547955036 scopus 로고
    • FDA regulated products and pregnant women, Available at Accessed October 25, 2006
    • FDA regulated products and pregnant women, 1994. Available at www.fda.gov/bbs/topics/ANSWERS/ANS00601.html Accessed October 25, 2006.
    • (1994)
  • 59
    • 16644402527 scopus 로고    scopus 로고
    • Pharmacokinetics and pharmacodynamics of atenolol during pregnancy and postpartum
    • Hebert MF, Carr DB, Anderson GD, et al. Pharmacokinetics and pharmacodynamics of atenolol during pregnancy and postpartum. J Clin Pharmacol 2005;45:25.
    • (2005) J Clin Pharmacol , vol.45 , pp. 25
    • Hebert, M.F.1    Carr, D.B.2    Anderson, G.D.3
  • 60
  • 61
    • 37549041520 scopus 로고    scopus 로고
    • Pharmacokinetics of labetalol in pregnancy
    • Available at
    • Pharmacokinetics of labetalol in pregnancy. Pharmacotherapy 2005;25:1519. Available at www.pharmacotherapy.org/pdf/free/Pharm2510_ACCP-Abstracts.pdf
    • (2005) Pharmacotherapy , vol.25 , pp. 1519
  • 65
    • 0038521433 scopus 로고    scopus 로고
    • Botanical dietary supplement use in peri- and postmenopausal women
    • Mahady GB, Parrot J, Lee C, Yun G S, Dan A. Botanical dietary supplement use in peri- and postmenopausal women. Menopause 2003;10:65.
    • (2003) Menopause , vol.10 , pp. 65
    • Mahady, G.B.1    Parrot, J.2    Lee, C.3    Yun, G.S.4    Dan, A.5
  • 66
    • 0346874440 scopus 로고    scopus 로고
    • The interaction between St John's wort and an oral contraceptive
    • Hall SD, Wang C, Huang SM, et al. The interaction between St John's wort and an oral contraceptive. Clin Pharmacol 2003;74:525.
    • (2003) Clin Pharmacol , vol.74 , pp. 525
    • Hall, S.D.1    Wang, C.2    Huang, S.M.3
  • 67
    • 12344312090 scopus 로고    scopus 로고
    • Use of complementary and alternative medicine among American women
    • Upchurch DM, Chyu L. Use of complementary and alternative medicine among American women. Womens Health Issues 2005;15:5.
    • (2005) Womens Health Issues , vol.15 , pp. 5
    • Upchurch, D.M.1    Chyu, L.2
  • 70
    • 34547943342 scopus 로고    scopus 로고
    • Physicians' desk reference: Levonorgestrel and ethinyl estradiol. Physicians' Desk Reference, edition 59. Montvale, NJ. Thompson PDR, 2005, 3311.
    • Physicians' desk reference: Levonorgestrel and ethinyl estradiol. Physicians' Desk Reference, edition 59. Montvale, NJ. Thompson PDR, 2005, pg. 3311.
  • 71
    • 1642441388 scopus 로고    scopus 로고
    • The effect of echinacea (Echinacea purpurea root) on cytochrome P450 activity in vivo
    • Gorski JC, Huang M-S, Pinto A, et al. The effect of echinacea (Echinacea purpurea root) on cytochrome P450 activity in vivo. Clin Pharmacol Ther 2004;75:89.
    • (2004) Clin Pharmacol Ther , vol.75 , pp. 89
    • Gorski, J.C.1    Huang, M.-S.2    Pinto, A.3
  • 72
    • 34547950992 scopus 로고    scopus 로고
    • Drug-drug, drug-dietary supplement, and drug-citrus fruit and other food onteractions - Labeling implications
    • Lam F, Huang S-M, Hall S, eds, New York: Marcel Dekker
    • Huang S-M, Temple R, Lesko LJ. Drug-drug, drug-dietary supplement, and drug-citrus fruit and other food onteractions - Labeling implications. In: Lam F, Huang S-M, Hall S, eds. Drug-herb interactions - Scientific and regulatory challenge. New York: Marcel Dekker, 2006.
    • (2006) Drug-herb interactions - Scientific and regulatory challenge
    • Huang, S.-M.1    Temple, R.2    Lesko, L.J.3
  • 73
    • 0038042814 scopus 로고    scopus 로고
    • Environmental dioxins and endometriosis
    • Rier S, Foster WG. Environmental dioxins and endometriosis. Semin Reprod Med 2003;21:145.
    • (2003) Semin Reprod Med , vol.21 , pp. 145
    • Rier, S.1    Foster, W.G.2
  • 74
    • 23744476869 scopus 로고    scopus 로고
    • Increased dioxin-like compounds in the serum of women with peritoneal endometriosis and deep endometriotic (adenomyotic) nodules
    • Heilier JF, Nackers F, Verougstraete V, Tonglet R, Lison D, Donnez J. Increased dioxin-like compounds in the serum of women with peritoneal endometriosis and deep endometriotic (adenomyotic) nodules. Fertil Steril 2005;84:305.
    • (2005) Fertil Steril , vol.84 , pp. 305
    • Heilier, J.F.1    Nackers, F.2    Verougstraete, V.3    Tonglet, R.4    Lison, D.5    Donnez, J.6
  • 77
    • 0038931405 scopus 로고    scopus 로고
    • Bayesian data mining in large frequency tables, with an application to the FDA spontaneous reporting system
    • DuMouchel W. Bayesian data mining in large frequency tables, with an application to the FDA spontaneous reporting system. Am Statistician 1999;53:177.
    • (1999) Am Statistician , vol.53 , pp. 177
    • DuMouchel, W.1
  • 78
    • 34547930960 scopus 로고    scopus 로고
    • The Office of Women's Health: Impact of research program [abstract] K-29
    • Available at Accessed April 28
    • Obias-Manno D, Scott P, Kaczmarczyk J, Pinnow E, Uhl K, OWH. The Office of Women's Health: Impact of research program [abstract] K-29. 206 FDA Science Forum. Available at www.cfsan.fda.gov/~frf/forum06/abs06ct.html#K Accessed April 28, 2006.
    • (2006) 206 FDA Science Forum
    • Obias-Manno, D.1    Scott, P.2    Kaczmarczyk, J.3    Pinnow, E.4    Uhl, K.5    OWH6
  • 79
    • 85030602838 scopus 로고    scopus 로고
    • Available at Accessed October 18, 2006
    • The critical path to new medical products. Available at www.fda.gov/oc/initiatives/criticalpath/ Accessed October 18, 2006.
    • The critical path to new medical products
  • 80
    • 34547929508 scopus 로고    scopus 로고
    • Workshop on sex differences and the Food and Drug Administration Critical Path Initiative
    • Available at
    • Shuren J. Workshop on sex differences and the Food and Drug Administration Critical Path Initiative Fed Reg 2006;71:59511. Available at www.fda.gov/OHRMS/DOCKETS/98fr/E6-16605.pdf
    • (2006) Fed Reg , vol.71 , pp. 59511
    • Shuren, J.1
  • 81
    • 34547943543 scopus 로고    scopus 로고
    • U.S. FDA. FDA and Duke Clinical Research Institute form partnership to collaborate on cardiac safety virtual. Available at www.fda.gov/bbs/topics/ news/2006/new01467.html
    • U.S. FDA. FDA and Duke Clinical Research Institute form partnership to collaborate on cardiac safety virtual. Available at www.fda.gov/bbs/topics/ news/2006/new01467.html


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.