-
1
-
-
0032495657
-
The Nuremberg Code: Hippocratic ethics and human rights
-
Shuster E. The Nuremberg Code: Hippocratic ethics and human rights. Lancet 1998;351:974.
-
(1998)
Lancet
, vol.351
, pp. 974
-
-
Shuster, E.1
-
2
-
-
0009741611
-
Women's participation in clinical studies
-
Mastroianni AC, Faden R, Federman D, eds. Washington, DC: National Academy Press
-
Women's participation in clinical studies. In: Mastroianni AC, Faden R, Federman D, eds. Washington, DC: National Academy Press, 1994:36.
-
(1994)
, pp. 36
-
-
-
3
-
-
0033549799
-
Proposed revisions to the Declaration of Helsinki - Will they weaken the ethical principles underlying human research?
-
Brennan TA. Proposed revisions to the Declaration of Helsinki - Will they weaken the ethical principles underlying human research? N Engl J Med 1999;341:527.
-
(1999)
N. Engl. J. Med.
, vol.341
, pp. 527
-
-
Brennan, T.A.1
-
4
-
-
0028043128
-
Historical background of clinical trials involving women and minorities
-
McCarthy CR. Historical background of clinical trials involving women and minorities. Acad Med 1994;69: 695.
-
(1994)
Acad. Med.
, vol.69
, pp. 695
-
-
McCarthy, C.R.1
-
5
-
-
33845586582
-
Legal considerations
-
Mastroianni AC, Faden R, Federman D, eds. Washington, DC: National Academy Press
-
Legal considerations. In: Mastroianni AC, Faden R, Federman D, eds. Washington, DC: National Academy Press, 1994:128.
-
(1994)
, pp. 128
-
-
-
6
-
-
0027732543
-
A legacy of distrust: African American and medical research
-
Gamble VN. A legacy of distrust: African American and medical research. Am J Prev Med 1993;9:35.
-
(1993)
Am. J. Prev. Med.
, vol.9
, pp. 35
-
-
Gamble, V.N.1
-
7
-
-
0031602582
-
Inclusion of women in clinical trials: A historical overview of scientific, ethical, and legal issues
-
Merkatz RB. Inclusion of women in clinical trials: A historical overview of scientific, ethical, and legal issues. J Obstet Gynecol Neonat Nurs 1998;27:78.
-
(1998)
J. Obstet. Gynecol. Neonat. Nurs.
, vol.27
, pp. 78
-
-
Merkatz, R.B.1
-
8
-
-
0027922323
-
Guideline for the study and evaluation of gender differences in the clinical evaluation of drugs
-
Department of Health and Human Services
-
Department of Health and Human Services. Guideline for the study and evaluation of gender differences in the clinical evaluation of drugs. Fed Reg 1993;58: 39406.
-
(1993)
Fed. Reg.
, vol.58
, pp. 39406
-
-
-
10
-
-
85039586109
-
Additional DHHS protections for pregnant women, human fetuses, and newborns involved as subjects in research, and pertaining to human in vitro fertilizations
-
Department of Health and Human Services
-
Department of Health and Human Services. Additional DHHS protections for pregnant women, human fetuses, and newborns involved as subjects in research, and pertaining to human in vitro fertilizations. Fed Reg 1998;63:27793.
-
(1998)
Fed. Reg.
, vol.63
, pp. 27793
-
-
-
11
-
-
85039582258
-
Additional protections pertaining to research, development, and related activities involving fetuses, pregnant women, and human in vitro fertilization
-
Department of Health and Human Services
-
Department of Health and Human Services. Additional protections pertaining to research, development, and related activities involving fetuses, pregnant women, and human in vitro fertilization. Fed Reg 2001;45:56780.
-
(2001)
Fed. Reg.
, vol.45
, pp. 56780
-
-
-
12
-
-
0347406347
-
Women's health: Women sufficiently represented in new drug testing, but FDA oversight needs improvement
-
United States General Accounting Office
-
United States General Accounting Office. Women's health: Women sufficiently represented in new drug testing, but FDA oversight needs improvement. Women in Clinical Drug Trials Letter 2001;1.
-
(2001)
Women in Clinical Drug Trials Letter
, pp. 1
-
-
-
13
-
-
0033668360
-
Drug labeling and risk perceptions of teratogenicity: A survey of pregnant Canadian women and their health professionals
-
Pole M, Einarson A, Pairaudeau N, Einarson T, Koren G. Drug labeling and risk perceptions of teratogenicity: A survey of pregnant Canadian women and their health professionals. J Clin Pharmacol 2000;40: 573.
-
(2000)
J. Clin. Pharmacol.
, vol.40
, pp. 573
-
-
Pole, M.1
Einarson, A.2
Pairaudeau, N.3
Einarson, T.4
Koren, G.5
-
14
-
-
0033951163
-
Safety of fluoxetine during the first trimester of pregnancy: A meta-analytical review of epidemiological studies
-
Addis A, Koren G. Safety of fluoxetine during the first trimester of pregnancy: A meta-analytical review of epidemiological studies. Psychol Med 2000;30:89.
-
(2000)
Psychol. Med.
, vol.30
, pp. 89
-
-
Addis, A.1
Koren, G.2
-
15
-
-
0024318111
-
Perception of teratogenic risk by pregnant women exposed to drugs and chemicals during the first trimester
-
Koren G, Bologa M, Long D, Feldman Y, Shear NH. Perception of teratogenic risk by pregnant women exposed to drugs and chemicals during the first trimester. Am J Obstet Gynecol 1989;160:1190.
-
(1989)
Am. J. Obstet. Gynecol.
, vol.160
, pp. 1190
-
-
Koren, G.1
Bologa, M.2
Long, D.3
Feldman, Y.4
Shear, N.H.5
-
16
-
-
0034058393
-
Treatment of human immunodeficiency virus during pregnancy: The shift from an exclusive focus on fetal protection to a more balanced approach
-
Kass NE, Taylor HA, Anderson J. Treatment of human immunodeficiency virus during pregnancy: The shift from an exclusive focus on fetal protection to a more balanced approach. Am J Obstet Gynecol 2000;182:856.
-
(2000)
Am. J. Obstet. Gynecol.
, vol.182
, pp. 856
-
-
Kass, N.E.1
Taylor, H.A.2
Anderson, J.3
-
17
-
-
85039587331
-
Prescription drug use during pregnancy among women in KPNW, 1993-1994
-
FDA Forum on Regulatory Sciences, Bethesda, MD
-
Weiss S, Vega A, McCloskey C, McFarland B, Corelle C. Prescription drug use during pregnancy among women in KPNW, 1993-1994. FDA Forum on Regulatory Sciences, Bethesda, MD, 1997.
-
(1997)
-
-
Weiss, S.1
Vega, A.2
McCloskey, C.3
McFarland, B.4
Corelle, C.5
-
18
-
-
0008761634
-
Risks to reproduction and offspring
-
Mastroianni AC, Faden R, Federman D, eds. Washington, DC: National Academy Press
-
Risks to reproduction and offspring. In: Mastroianni AC, Faden R, Federman D, eds. Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies. Vol. 1. Washington, DC: National Academy Press, 1994:175.
-
(1994)
Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies
, vol.1
, pp. 175
-
-
-
19
-
-
85039587907
-
FDA/NIH Conference: Clinical pharmacology during pregnancy, addressing clinical needs through science, December 4, 2000
-
Department of Health and Human Services, Food and Drug Administration, National Institute for Child Health and Human Development
-
Department of Health and Human Services, Food and Drug Administration, National Institute for Child Health and Human Development. FDA/NIH Conference: Clinical pharmacology during pregnancy, addressing clinical needs through science, December 4, 2000. Fed Reg 2000.
-
(2000)
Fed. Reg.
-
-
-
20
-
-
85039565103
-
FDA/NIH Conference: Clinical pharmacology during pregnancy, addressing clinical needs through science, December 5, 2000
-
Department of Health and Human Services, Food and Drug Administration, National Institute for Child Health and Human Development
-
Department of Health and Human Services, Food and Drug Administration, National Institute for Child Health and Human Development. FDA/NIH Conference: Clinical pharmacology during pregnancy, addressing clinical needs through science, December 5, 2000. Fed Reg 2000.
-
(2000)
Fed. Reg.
-
-
-
21
-
-
0029787288
-
Asthma treatment in pregnancy: A randomized controlled study
-
Wendel PJ, Ramin SM, Barnett-Hamm C, Rowe TF, Cunningham GF. Asthma treatment in pregnancy: A randomized controlled study. Am J Obstet Gynecol 1996;175:150.
-
(1996)
Am. J. Obstet. Gynecol.
, vol.175
, pp. 150
-
-
Wendel, P.J.1
Ramin, S.M.2
Barnett-Hamm, C.3
Rowe, T.F.4
Cunningham, G.F.5
-
22
-
-
0346145472
-
Guidance for industry: Establishing pregnancy registries
-
U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research
-
U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research. Guidance for industry: Establishing pregnancy registries. Fed Reg 1999.
-
(1999)
Fed. Reg.
-
-
-
23
-
-
0347406345
-
Reviewer guidance: Evaluation of human pregnancy outcome data
-
U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research
-
U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research. Reviewer guidance: Evaluation of human pregnancy outcome data. Fed Reg 1999.
-
(1999)
Fed. Reg.
-
-
-
24
-
-
85039584946
-
Safe Motherhood Act for Research and Treatment
-
107th Congress. (Smart Mom Act). Legislative Updates S. 2328/H.R. 4602. 2-21-2003
-
107th Congress. Safe Motherhood Act for Research and Treatment (Smart Mom Act). Legislative Updates S. 2328/H.R. 4602. 2003. 2-21-2003.
-
(2003)
-
-
-
25
-
-
0036596589
-
Safe Motherhood Act for Research and Treatment
-
144
-
Harkin T. Safe Motherhood Act for Research and Treatment. J Am Med Wom Assoc 2002;57:144, 158.
-
(2002)
J. Am. Med. Wom. Assoc.
, vol.57
, pp. 158
-
-
Harkin, T.1
-
26
-
-
0037732584
-
The National Children's Study of Environmental Effects on Child Health and Development
-
Branum AM, Collman GW, Correa A, et al. The National Children's Study of Environmental Effects on Child Health and Development, Environ Health Perspect 2003;3:642.
-
(2003)
Environ. Health Perspect.
, vol.3
, pp. 642
-
-
Branum, A.M.1
Collman, G.W.2
Correa, A.3
-
27
-
-
0346775803
-
Concept paper on pregnancy labeling: Summary of comments from a public hearing and model pregnancy labeling based on recommendations
-
Concept paper on pregnancy labeling: Summary of comments from a public hearing and model pregnancy labeling based on recommendations. Preg-labeling Hearing Summary, 1999.
-
(1999)
Preg-labeling Hearing Summary
-
-
-
28
-
-
0027198952
-
Women in clinical trials of new drugs - A change in Food and Drug Administration policy
-
Merkatz RB, Temple R, Sobel S, Feiden K, Kessler DA. Women in clinical trials of new drugs - A change in Food and Drug Administration policy. N Engl J Med 1993;329:292.
-
(1993)
N. Engl. J. Med.
, vol.329
, pp. 292
-
-
Merkatz, R.B.1
Temple, R.2
Sobel, S.3
Feiden, K.4
Kessler, D.A.5
-
29
-
-
0027362889
-
FDA policy on women in drug trials
-
Caschetta MB, Chavkin W, McGovern T, Kessler DA, Merkatz RB, Temple R. FDA policy on women in drug trials. N Engl J Med 1993;329:1815.
-
(1993)
N. Engl. J. Med.
, vol.329
, pp. 1815
-
-
Caschetta, M.B.1
Chavkin, W.2
McGovern, T.3
Kessler, D.A.4
Merkatz, R.B.5
Temple, R.6
-
30
-
-
26544431728
-
Reproductive and developmental toxicology
-
FDA
-
Schwetz BA. Reproductive and developmental toxicology. FDA, 2003.
-
(2003)
-
-
Schwetz, B.A.1
-
31
-
-
0346775802
-
Guidance for industry: Considerations for reproductive toxicity studies for preventive vaccines for infectious disease indications
-
U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research
-
U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research. Guidance for industry: Considerations for reproductive toxicity studies for preventive vaccines for infectious disease indications. Fed Reg 2000.
-
(2000)
Fed. Reg.
-
-
-
32
-
-
0348037192
-
Draft guidance for reviewers on the integration of study results to assess concerns about human reproductive and developmental toxicities
-
U.S. Department of Health and Human Services and Food and Drug Administration
-
U.S. Department of Health and Human Services and Food and Drug Administration. Draft guidance for reviewers on the integration of study results to assess concerns about human reproductive and developmental toxicities. Fed Reg 2001;66:219.
-
(2001)
Fed. Reg.
, vol.66
, pp. 219
-
-
-
33
-
-
85039584823
-
Physiologic changes in pregnancy: Effect on drug disposition
-
FDA Center for Drug Evaluation and Research
-
Fredericksen MC. Physiologic changes in pregnancy: Effect on drug disposition. FDA Center for Drug Evaluation and Research, 2000.
-
(2000)
-
-
Fredericksen, M.C.1
-
34
-
-
0032728821
-
Pharmacokinetics of didanosine in antepartum and postpartum human immunodeficiency virus-infected pregnant women and their neonates: An AIDS Clinical Trials Group study
-
Wang Y, Livingston E, Patil S, et al. Pharmacokinetics of didanosine in antepartum and postpartum human immunodeficiency virus-infected pregnant women and their neonates: An AIDS Clinical Trials Group study. J Infect Dis 1999;180:1536.
-
(1999)
J. Infect. Dis.
, vol.180
, pp. 1536
-
-
Wang, Y.1
Livingston, E.2
Patil, S.3
-
35
-
-
0035124720
-
Maternal-fetal transfer and amniotic fluid accumulation of lamivudine in human immunodeficiency virus-infected pregnant women
-
Mandelbrot L, Peytavin G, Firtion G, Farinotti R. Maternal-fetal transfer and amniotic fluid accumulation of lamivudine in human immunodeficiency virus-infected pregnant women. Am J Obstet Gynecol 2001; 184:153.
-
(2001)
Am. J. Obstet. Gynecol.
, vol.184
, pp. 153
-
-
Mandelbrot, L.1
Peytavin, G.2
Firtion, G.3
Farinotti, R.4
-
36
-
-
0034062102
-
Are SSRIs safe for pregnant and breastfeeding women?
-
Misri S, Burgmann A, Kostaras D. Are SSRIs safe for pregnant and breastfeeding women? Can Fam Phys 2000;46:626.
-
(2000)
Can. Fam. Phys.
, vol.46
, pp. 626
-
-
Misri, S.1
Burgmann, A.2
Kostaras, D.3
-
37
-
-
0034051589
-
Use of psychoactive medication during pregnancy and possible effects on the fetus and newborn
-
American Academy of Pediatrics
-
American Academy of Pediatrics. Use of psychoactive medication during pregnancy and possible effects on the fetus and newborn. Pediatrics 2000;105: 880.
-
(2000)
Pediatrics
, vol.105
, pp. 880
-
-
-
38
-
-
0033530293
-
Pharmacologic treatment of depression during pregnancy
-
Wisner KL, Gelenberg AJ, Leonard H, Zarin D, Ellen F. Pharmacologic treatment of depression during pregnancy. JAMA 1999;282:1264.
-
(1999)
JAMA
, vol.282
, pp. 1264
-
-
Wisner, K.L.1
Gelenberg, A.J.2
Leonard, H.3
Zarin, D.4
Ellen, F.5
-
39
-
-
0034620112
-
Fall in mean arterial pressure and fetal growth restriction in pregnancy hypertension: A meta-analysis
-
von Dadelszen P, Ornstein MP, Bull SB, Logan AG, Koren G, Magee LA. Fall in mean arterial pressure and fetal growth restriction in pregnancy hypertension: A meta-analysis. Lancet 2000;355:87.
-
(2000)
Lancet
, vol.355
, pp. 87
-
-
von Dadelszen, P.1
Ornstein, M.P.2
Bull, S.B.3
Logan, A.G.4
Koren, G.5
Magee, L.A.6
-
40
-
-
0033988361
-
Risks and benefits of β-receptor blockers for pregnancy hypertension: Overview of the randomized trials
-
Magee LA, Elran E, Bull SB, Logan AG, Koren G. Risks and benefits of β-receptor blockers for pregnancy hypertension: Overview of the randomized trials. Eur J Obstet Gynecol Reprod Biol 2000;88:15.
-
(2000)
Eur. J. Obstet. Gynecol. Reprod. Biol.
, vol.88
, pp. 15
-
-
Magee, L.A.1
Elran, E.2
Bull, S.B.3
Logan, A.G.4
Koren, G.5
-
41
-
-
0037236359
-
Epilepsy and pregnancy: Report of an Epilepsy Research Foundation Workshop
-
Barrett C, Richens A. Epilepsy and pregnancy: Report of an Epilepsy Research Foundation Workshop. Epilepsy Res 2003;52:147.
-
(2003)
Epilepsy Res.
, vol.52
, pp. 147
-
-
Barrett, C.1
Richens, A.2
-
42
-
-
0037399123
-
Anti-epileptic drugs in pregnancy: Current safety and other issues
-
Morrow JI, Craig JJ. Anti-epileptic drugs in pregnancy: Current safety and other issues. Expert Opin Pharmacother 2003;4:445.
-
(2003)
Expert. Opin. Pharmacother.
, vol.4
, pp. 445
-
-
Morrow, J.I.1
Craig, J.J.2
-
43
-
-
0031201383
-
Skin drugs in pregnancy - Which ones to use?
-
233
-
Guenther L. Skin drugs in pregnancy - Which ones to use? Dermatol Nurs 1997;9:233, 265.
-
(1997)
Dermatol. Nurs.
, vol.9
, pp. 265
-
-
Guenther, L.1
-
44
-
-
0034026235
-
Prospective, controlled, multicentre study of loperamide in pregnancy
-
Einarson A, Mastroiacovo P, Arnon J, et al. Prospective, controlled, multicentre study of loperamide in pregnancy. Can J Gastroenterol 2000;14:185.
-
(2000)
Can. J. Gastroenterol.
, vol.14
, pp. 185
-
-
Einarson, A.1
Mastroiacovo, P.2
Arnon, J.3
-
45
-
-
0034643078
-
The effects of immunosuppressive and anti-inflammatory medications on fertility, pregnancy, and lactation
-
Janssen N, Genta MS. The effects of immunosuppressive and anti-inflammatory medications on fertility, pregnancy, and lactation. Arch Intern Med 2000;160:610.
-
(2000)
Arch. Intern. Med.
, vol.160
, pp. 610
-
-
Janssen, N.1
Genta, M.S.2
-
46
-
-
1842376945
-
Discrepancies between meta-analyses and subsequent large randomized controlled trials
-
LeLorier J, Gregoire G, Benhaddad A, Lapierre J, Derderian F. Discrepancies between meta-analyses and subsequent large randomized controlled trials. N Engl J Med 1997;337:536.
-
(1997)
N. Engl. J. Med.
, vol.337
, pp. 536
-
-
LeLorier, J.1
Gregoire, G.2
Benhaddad, A.3
Lapierre, J.4
Derderian, F.5
-
47
-
-
0029268549
-
Exclusion of pregnant women from research protocols: Unethical and illegal
-
Hall JK. Exclusion of pregnant women from research protocols: Unethical and illegal. IRB: A Review of Human Subjects Research 1995;17:1.
-
(1995)
IRB: A Review of Human Subjects Research
, vol.17
, pp. 1
-
-
Hall, J.K.1
-
48
-
-
0032808220
-
Ethical considerations in research involving pregnant women
-
The American College of Obstetricians and Gynecologists
-
The American College of Obstetricians and Gynecologists. Ethical considerations in research involving pregnant women. Wom Health Issues 1999;9:194.
-
(1999)
Wom. Health Issues
, vol.9
, pp. 194
-
-
-
49
-
-
0345311668
-
Ethical issues related to the inclusion of pregnant women in clinical trials
-
Mastroianni AC, Faden R, Federman D, eds. Washington, DC: National Academy Press
-
Robertson J. Ethical issues related to the inclusion of pregnant women in clinical trials. In: Mastroianni AC, Faden R, Federman D, eds. Woman and Health Reserch: Ethical and Legal Issues of Including Women in Clinical Studies. Vol. 2. Washington, DC: National Academy Press, 1994:18.
-
(1994)
Woman and Health Reserch: Ethical and Legal Issues of Including Women in Clinical Studies
, vol.2
, pp. 18
-
-
Robertson, J.1
-
50
-
-
0347406342
-
Product liability - What is the current situation and will it change (and how) when more women are included in studies?
-
Washington, DC: Food and Drug Law Institute
-
Reisman EK. Product liability - What is the current situation and will it change (and how) when more women are included in studies? Washington, DC: Food and Drug Law Institute, 1992.
-
(1992)
-
-
Reisman, E.K.1
-
51
-
-
0032058925
-
A charter for ethical research in maternity care
-
A charter for ethical research in maternity care. Nurs Ethics 1998;5:256.
-
(1998)
Nurs. Ethics
, vol.5
, pp. 256
-
-
-
52
-
-
0030092757
-
Harms of excluding pregnant women from clinical research: The case of HIV-infected pregnant women
-
Kass NE, Taylor HA, King PA. Harms of excluding pregnant women from clinical research: The case of HIV-infected pregnant women. J Law Med Ethics 1996;24:36.
-
(1996)
J. Law Med. Ethics
, vol.24
, pp. 36
-
-
Kass, N.E.1
Taylor, H.A.2
King, P.A.3
-
53
-
-
0023214587
-
Human experimentation in perinatology
-
Silverman WA. Human experimentation in perinatology. Clin Perinatol 1987;14:403.
-
(1987)
Clin. Perinatol.
, vol.14
, pp. 403
-
-
Silverman, W.A.1
|