-
1
-
-
0003918497
-
-
Washington, DC: Government Printing Office; Report No. HEW 77-3040
-
Food and Drug Administration (FDA), Department of Health, Education, and Welfare. General Considerations for the Clinical Evaluation of Drugs. Washington, DC: Government Printing Office; Report No. HEW 77-3040, 1977.
-
(1977)
General Considerations for the Clinical Evaluation of Drugs
-
-
-
2
-
-
0024493884
-
The regulation of investigational drugs
-
Kessler DA. The regulation of investigational drugs. N Engl J Med 1989;320:281-288.
-
(1989)
N Engl J Med
, vol.320
, pp. 281-288
-
-
Kessler, D.A.1
-
3
-
-
1242335135
-
-
th World Medical Assembly, Helsinki, Finland, June 1964
-
th World Medical Assembly, Helsinki, Finland, June 1964.
-
-
-
-
5
-
-
1242335134
-
Protection of human subjects: Fetuses, pregnant women, in vitro fertilization. No. 45CR46 Subpart B
-
August 8
-
Protection of human subjects: Fetuses, pregnant women, in vitro fertilization. No. 45CR46 Subpart B. Federal Register, August 8, 1975.
-
(1975)
Federal Register
-
-
-
6
-
-
1242290254
-
-
Equal Employment Opportunity, Pregnancy Discrimination Act of 1978, 92 Statute 2076, 42 USC 2000e(k), 29 Code of Federal Regulations (C.F.R.) Part 1604.10. Rules and Regulations, 44, No. 78. Federal Register, April 20, 1979
-
Equal Employment Opportunity, Pregnancy Discrimination Act of 1978, 92 Statute 2076, 42 USC 2000e(k), 29 Code of Federal Regulations (C.F.R.) Part 1604.10. Rules and Regulations, 44, No. 78. Federal Register, April 20, 1979.
-
-
-
-
7
-
-
0015225140
-
Adenocarcinoma of the vagina: Association of maternal stilbesterol therapy with tumor appearances in young women
-
Herbst AI, Ulfelder H, Poskanzer DC. Adenocarcinoma of the vagina: Association of maternal stilbesterol therapy with tumor appearances in young women. N Engl J Med 1971;284:878-881.
-
(1971)
N Engl J Med
, vol.284
, pp. 878-881
-
-
Herbst, A.I.1
Ulfelder, H.2
Poskanzer, D.C.3
-
8
-
-
0019409070
-
Underrepresentation of women in new drug trials
-
Kinney EL, Trautmann J, Gold JA, et al. Underrepresentation of women in new drug trials. Ann Intern Med 1981;95:495-499.
-
(1981)
Ann Intern Med
, vol.95
, pp. 495-499
-
-
Kinney, E.L.1
Trautmann, J.2
Gold, J.A.3
-
10
-
-
1242267575
-
Federal Policy for Protection of Human Subjects. The Common Rule. 56, 28002, Part 46
-
June 18
-
Federal Policy for Protection of Human Subjects. The Common Rule. 56, 28002, Part 46. Federal Register, June 18, 1991.
-
(1991)
Federal Register
-
-
-
12
-
-
0003441260
-
Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research
-
March 18
-
National Institutes of Health (NIH). Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research. NIH Guide, March 18, 1994.
-
(1994)
NIH Guide
-
-
-
13
-
-
0003568354
-
-
Committee on the Ethical and Legal Issues Relating to the Inclusion of Women in Clinical Studies. Washington, DC: National Academy Press
-
Institute of Medicine. Committee on the Ethical and Legal Issues Relating to the Inclusion of Women in Clinical Studies. Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies. Vol 1. Washington, DC: National Academy Press; 1994.
-
(1994)
Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies
, vol.1
-
-
-
14
-
-
0027922323
-
Guideline for the study and evaluation of gender differences in the clinical evaluation of drugs. No. 58-FR-39406
-
July 19
-
Food and Drug Administration (FDA). Guideline for the study and evaluation of gender differences in the clinical evaluation of drugs. No. 58-FR-39406. Federal Register, July 19, 1993.
-
(1993)
Federal Register
-
-
-
15
-
-
0027198952
-
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, et al. 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; 329:292-296.
-
(1993)
N Engl J Med
, vol.329
, pp. 292-296
-
-
Merkatz, R.B.1
Temple, R.2
Subel, S.3
-
16
-
-
0033725193
-
Pharmacokinetic analysis of bioequivalence trials: Implications for sex-related issues in clinical pharmacology and biopharmaceutics
-
Chen ML, Lee SC, Ng MJ, et al. Pharmacokinetic analysis of bioequivalence trials: Implications for sex-related issues in clinical pharmacology and biopharmaceutics. Clin Pharmacol Ther 2000; 68:510-521.
-
(2000)
Clin Pharmacol Ther
, vol.68
, pp. 510-521
-
-
Chen, M.L.1
Lee, S.C.2
Ng, M.J.3
-
17
-
-
18544397972
-
Participation of women in clinical trials of drug therapies: A context for the controversies
-
Prout MN, Fish SS. Participation of women in clinical trials of drug therapies: A context for the controversies. Medscape Women's Health eJournal 2001;6(5).
-
(2001)
Medscape Women's Health eJournal
, vol.6
, Issue.5
-
-
Prout, M.N.1
Fish, S.S.2
-
19
-
-
1242335139
-
-
Available at www.estrogen-replacement-side-effects.com. Accessed May 2003.
-
-
-
-
20
-
-
1242312584
-
-
Women's Health Initiative (WHI), Department of Health and Human Services, National Institutes of Health, 2003. Available at: www.nhlbi.nih.gov/whi/index/html.
-
(2003)
-
-
-
21
-
-
0037125379
-
Risks and benefits of estrogen plus progestin in healthy postmenopausal women: Principal results from the WHI randomized controlled study
-
Writing Group for the Women's Health Initiative Investigators. Risks and benefits of estrogen plus progestin in healthy postmenopausal women: Principal results from the WHI randomized controlled study. JAMA 2002;288:321-333.
-
(2002)
JAMA
, vol.288
, pp. 321-333
-
-
-
23
-
-
0038386058
-
Estrogen plus progestin and the incidence of dementia and mild cognitive impairment in postmenopausal women: The Women's Health Initiative memory study: A randomized controlled trial
-
Shumaker SA, Legault C, Thal L, et al. Estrogen plus progestin and the incidence of dementia and mild cognitive impairment in postmenopausal women: The Women's Health Initiative memory study: A randomized controlled trial. JAMA 2003;289:2651-2662.
-
(2003)
JAMA
, vol.289
, pp. 2651-2662
-
-
Shumaker, S.A.1
Legault, C.2
Thal, L.3
|