메뉴 건너뛰기




Volumn 78, Issue 5, 2005, Pages 445-452

Women in early-phase clinical drug trials: Have things changed over the past 20 years?

Author keywords

[No Author keywords available]

Indexed keywords

AMLODIPINE; ANTI HUMAN IMMUNODEFICIENCY VIRUS AGENT; CHLORZOXAZONE; CISAPRIDE; CLOZAPINE; CYCLOSPORIN; CYCLOSPORIN A; DESIPRAMINE; DIAZEPAM; DIETHYLSTILBESTROL; DIGOXIN; ERYTHROMYCIN; ETOPOSIDE; EVEROLIMUS; HALOFANTRINE; HALOPERIDOL; HEPARIN; HYDROXYMETHYLGLUTARYL COENZYME A REDUCTASE INHIBITOR; MEFLOQUINE; MEVINOLIN; MIDAZOLAM; NEUROLEPTIC AGENT; NIFEDIPINE; PARACETAMOL; RAPAMYCIN; SAQUINAVIR; SOTALOL; THALIDOMIDE; UNINDEXED DRUG; VERAPAMIL;

EID: 28144446779     PISSN: 00099236     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.clpt.2005.08.016     Document Type: Note
Times cited : (31)

References (57)
  • 1
    • 28144447778 scopus 로고    scopus 로고
    • Sex differences in pharmacokinetics and pharmacodynamics
    • 4th ed. American College of Clinical Pharmacy Kansas City (MO)
    • P.F. Smith, Ku Yi-Min Sex differences in pharmacokinetics and pharmacodynamics Pharmacotherapy self-assessment program 4th ed. 2002 American College of Clinical Pharmacy Kansas City (MO) Book 11: Women's health
    • (2002) Pharmacotherapy Self-assessment Program
    • Smith, P.F.1    Ku, Y.2
  • 2
    • 0036290013 scopus 로고    scopus 로고
    • How important are gender differences in pharmacokinetics?
    • B. Meibohm, I. Beierle, H. Derendorf How important are gender differences in pharmacokinetics? Clin Pharmacokinet 41 2002 329 342
    • (2002) Clin Pharmacokinet , vol.41 , pp. 329-342
    • Meibohm, B.1    Beierle, I.2    Derendorf, H.3
  • 3
    • 0031742830 scopus 로고    scopus 로고
    • Influence of gender on the pharmacokinetics and pharmacodynamics of drugs
    • P.A. Thuermann, B.C. Hompesch Influence of gender on the pharmacokinetics and pharmacodynamics of drugs Int J Clin Pharmacol Ther 36 1998 586 590
    • (1998) Int J Clin Pharmacol Ther , vol.36 , pp. 586-590
    • Thuermann, P.A.1    Hompesch, B.C.2
  • 5
    • 11944274532 scopus 로고    scopus 로고
    • The influence of age and sex on the clearance of cytochrome P450 3A substrates
    • M.M. Cotreau, L.L. von Moltke, D.J. Greenblatt The influence of age and sex on the clearance of cytochrome P450 3A substrates Clin Pharmacokinet 44 2005 33 60
    • (2005) Clin Pharmacokinet , vol.44 , pp. 33-60
    • Cotreau, M.M.1    Von Moltke, L.L.2    Greenblatt, D.J.3
  • 6
    • 0019409070 scopus 로고
    • Underrepresentation of women in new drug trials: Ramifications and remedies
    • E.L. Kinney, J. Trautmann, J.A. Gold, E.S. Vessel, R. Zelis Underrepresentation of women in new drug trials ramifications and remedies Ann Intern Med 95 1981 495 499
    • (1981) Ann Intern Med , vol.95 , pp. 495-499
    • Kinney, E.L.1    Trautmann, J.2    Gold, J.A.3    Vessel, E.S.4    Zelis, R.5
  • 7
    • 0027323308 scopus 로고
    • Underrepresentation of women in clinical drug trials
    • D.L. Schmucker, E.S. Vesell Underrepresentation of women in clinical drug trials Clin Pharmacol Ther 54 1993 11 15
    • (1993) Clin Pharmacol Ther , vol.54 , pp. 11-15
    • Schmucker, D.L.1    Vesell, E.S.2
  • 8
    • 0033932913 scopus 로고    scopus 로고
    • Women subjects in NIH-funded clinical research literature: Lack of progress in both representation and analysis by sex
    • R.M. Vidaver, B. Lafleur, C. Tong, R. Bradshaw, S.A. Marts Women subjects in NIH-funded clinical research literature lack of progress in both representation and analysis by sex J Womens Health Gend Based Med 9 2000 495 504
    • (2000) J Womens Health Gend Based Med , vol.9 , pp. 495-504
    • Vidaver, R.M.1    Lafleur, B.2    Tong, C.3    Bradshaw, R.4    Marts, S.A.5
  • 9
    • 0003918497 scopus 로고
    • Food and Drug Administration Government Printing Office (US) Washington (DC)
    • Food and Drug Administration General considerations for the clinical evaluation of drugs 1977 Government Printing Office (US) Washington (DC) Dept. of Health, Education, and Welfare (US) Publication No.: (FDA) 77-3040
    • (1977) General Considerations for the Clinical Evaluation of Drugs
  • 11
    • 0028033394 scopus 로고
    • Historical background of changes in FDA policy on the study and evaluation of drugs in women
    • R.B. Merkatz, S.W. Junod Historical background of changes in FDA policy on the study and evaluation of drugs in women Acad Med 69 1994 703 707
    • (1994) Acad Med , vol.69 , pp. 703-707
    • Merkatz, R.B.1    Junod, S.W.2
  • 12
    • 0027333065 scopus 로고
    • Determinants of accrual of women to a large, multicenter clinical trial program of human immunodeficiency virus infection
    • The AIDS Clinical Trials Group Cotton D.J.*Finkelstein D.M.*He W.*Feinberg J.
    • The AIDS Clinical Trials Group D.J. Cotton, D.M. Finkelstein, W. He, J. Feinberg Determinants of accrual of women to a large, multicenter clinical trial program of human immunodeficiency virus infection J Acquir Immune Defic Syndr 6 1993 1322 1328
    • (1993) J Acquir Immune Defic Syndr , vol.6 , pp. 1322-1328
  • 13
    • 28144443902 scopus 로고    scopus 로고
    • Women in clinical trials: Screening and consent issues revisited
    • T. Van den Bosch, D. Mattison, B. Ward Women in clinical trials screening and consent issues revisited Res Pract 1 2000 17 20
    • (2000) Res Pract , vol.1 , pp. 17-20
    • Van Den Bosch, T.1    Mattison, D.2    Ward, B.3
  • 14
    • 0024463442 scopus 로고
    • Drug studies in women of childbearing age: Ethical and methodological issues
    • U. Halbreich, S.W. Carson Drug studies in women of childbearing age ethical and methodological issues J Clin Psychopharmacol 9 1989 328 333
    • (1989) J Clin Psychopharmacol , vol.9 , pp. 328-333
    • Halbreich, U.1    Carson, S.W.2
  • 15
  • 17
    • 0035514875 scopus 로고    scopus 로고
    • An interaction between the cytochrome P450 probe substrates chlorzoxazone (CYP2EI) and midazolam (CYP3A)
    • J.L. Palmer, R.J. Scott, A. Gibson, M. Dickins, S. Pleasance An interaction between the cytochrome P450 probe substrates chlorzoxazone (CYP2EI) and midazolam (CYP3A) Br J Clin Pharmacol 52 2001 555 561
    • (2001) Br J Clin Pharmacol , vol.52 , pp. 555-561
    • Palmer, J.L.1    Scott, R.J.2    Gibson, A.3    Dickins, M.4    Pleasance, S.5
  • 18
    • 0035515965 scopus 로고    scopus 로고
    • Electro-encephalographic effect and serum concentrations after nasal and intravenous administration of diazepam to healthy volunteers
    • K. Lindhardt, S. Gizurarson, S.B. Stefansson, D.R. Olafsson, E. Bechgaard Electro-encephalographic effect and serum concentrations after nasal and intravenous administration of diazepam to healthy volunteers Br J Clin Pharmacol 52 2001 521 527
    • (2001) Br J Clin Pharmacol , vol.52 , pp. 521-527
    • Lindhardt, K.1    Gizurarson, S.2    Stefansson, S.B.3    Olafsson, D.R.4    Bechgaard, E.5
  • 21
    • 0035035783 scopus 로고    scopus 로고
    • Population-based investigation of relative clearance of digoxin in Japanese neonates and infants by multiple-through screen analysis
    • F. Suematso, E. Yukawa, M. Yukawa, M. Minemoto, S. Ohdo, S. Higuchi Population-based investigation of relative clearance of digoxin in Japanese neonates and infants by multiple-through screen analysis Eur J Clin Pharmacol 57 2001 19 24
    • (2001) Eur J Clin Pharmacol , vol.57 , pp. 19-24
    • Suematso, F.1    Yukawa, E.2    Yukawa, M.3    Minemoto, M.4    Ohdo, S.5    Higuchi, S.6
  • 22
    • 0035041087 scopus 로고    scopus 로고
    • Effect of digoxin noncompliance on hospitalization and mortality in patients with heart failure in long-term therapy: A prospective cohort study
    • T. Miura, R. Kojima, M. Mizutani, Y. Shiga, F. Takatsu, Y. Suzuki Effect of digoxin noncompliance on hospitalization and mortality in patients with heart failure in long-term therapy a prospective cohort study Eur J Clin Pharmacol 57 2001 77 83
    • (2001) Eur J Clin Pharmacol , vol.57 , pp. 77-83
    • Miura, T.1    Kojima, R.2    Mizutani, M.3    Shiga, Y.4    Takatsu, F.5    Suzuki, Y.6
  • 25
    • 0034767710 scopus 로고    scopus 로고
    • Acetaminophen analgesia in children: Placebo effect and pain resolution after tonsillectomy
    • B.J. Anderson, G.A. Woollard, N.H.G. Holford Acetaminophen analgesia in children placebo effect and pain resolution after tonsillectomy Eur J Clin Pharmacol 57 2001 559 569
    • (2001) Eur J Clin Pharmacol , vol.57 , pp. 559-569
    • Anderson, B.J.1    Woollard, G.A.2    Holford, N.H.G.3
  • 26
    • 0035337643 scopus 로고    scopus 로고
    • Plasma concentration of lovastatin acid are markedly increased by gemfibrozil but not by bezafibrate
    • C. Kyrklund, J. Backman, K.T. Kivisto, M. Neuvonen, J. Laitila, P. Neuvonen Plasma concentration of lovastatin acid are markedly increased by gemfibrozil but not by bezafibrate Clin Pharmacol Ther 69 2001 340 345
    • (2001) Clin Pharmacol Ther , vol.69 , pp. 340-345
    • Kyrklund, C.1    Backman, J.2    Kivisto, K.T.3    Neuvonen, M.4    Laitila, J.5    Neuvonen, P.6
  • 27
    • 0035657076 scopus 로고    scopus 로고
    • Association of polymorphism in the cytochrome CYP2D6 and the efficacy and the tolerability of simvastatin
    • A. Mulder, H. Van Lijf, M.A. Bon, F.A. van den Bergh, D.J. Touw, C. Neef Association of polymorphism in the cytochrome CYP2D6 and the efficacy and the tolerability of simvastatin Clin Pharmacol Ther 70 2001 546 551
    • (2001) Clin Pharmacol Ther , vol.70 , pp. 546-551
    • Mulder, A.1    Van Lijf, H.2    Bon, M.A.3    Van Den Bergh, F.A.4    Touw, D.J.5    Neef, C.6
  • 30
    • 0034827018 scopus 로고    scopus 로고
    • Determination of in vivo absorption, metabolism and transport of drugs by the human intestinal wall and liver with a novel perfusion technique
    • O. Von Richter, B. Greiner, M.F. Fromm, R. Fraser, T. Omari, M.L. Barclay Determination of in vivo absorption, metabolism and transport of drugs by the human intestinal wall and liver with a novel perfusion technique Clin Pharmacol Ther 70 2001 217 227
    • (2001) Clin Pharmacol Ther , vol.70 , pp. 217-227
    • Von Richter, O.1    Greiner, B.2    Fromm, M.F.3    Fraser, R.4    Omari, T.5    Barclay, M.L.6
  • 31
    • 0035336164 scopus 로고    scopus 로고
    • Disposition and pharmacologic effects of R/S-verapamil in patients with chronic atrial fibrillation: An investigation comparing single and multiple dosing
    • D. Busse, M. Fromm, K. Morike, S. Drescher, V. Kuhlkamp, M. Eichelbaum Disposition and pharmacologic effects of R/S-verapamil in patients with chronic atrial fibrillation an investigation comparing single and multiple dosing Clin Pharmacol Ther 69 2001 324 332
    • (2001) Clin Pharmacol Ther , vol.69 , pp. 324-332
    • Busse, D.1    Fromm, M.2    Morike, K.3    Drescher, S.4    Kuhlkamp, V.5    Eichelbaum, M.6
  • 32
    • 0035675720 scopus 로고    scopus 로고
    • Contrasting effects of verapamil and amlodipine on cardiovascular stress responses in hypertension
    • J. Lefrandt, J. Heitmann, K. Sevre, M. Castellano, M. Hausberg, M. Fallon Contrasting effects of verapamil and amlodipine on cardiovascular stress responses in hypertension Br J Clin Pharmacol 52 2001 687 692
    • (2001) Br J Clin Pharmacol , vol.52 , pp. 687-692
    • Lefrandt, J.1    Heitmann, J.2    Sevre, K.3    Castellano, M.4    Hausberg, M.5    Fallon, M.6
  • 33
    • 0035660993 scopus 로고    scopus 로고
    • Effect of influenza vaccination on serum clozapine and its main metabolite concentrations in patients with schizophrenia
    • K. Raaska, V. Raitasuo, P.J. Neuvonen Effect of influenza vaccination on serum clozapine and its main metabolite concentrations in patients with schizophrenia Eur J Clin Pharmacol 57 2001 705 708
    • (2001) Eur J Clin Pharmacol , vol.57 , pp. 705-708
    • Raaska, K.1    Raitasuo, V.2    Neuvonen, P.J.3
  • 34
    • 0035460056 scopus 로고    scopus 로고
    • Comparison of clozapine and haloperidol on some autonomic and psychomotor functions and on serum prolactin concentration in healthy subjects
    • J.L. Pretorius, M. Phillips, R.W. Langley, E. Szabadi, C.M. Bradshaw Comparison of clozapine and haloperidol on some autonomic and psychomotor functions and on serum prolactin concentration in healthy subjects Br J Clin Pharmacol 52 2001 322 326
    • (2001) Br J Clin Pharmacol , vol.52 , pp. 322-326
    • Pretorius, J.L.1    Phillips, M.2    Langley, R.W.3    Szabadi, E.4    Bradshaw, C.M.5
  • 39
    • 0035029633 scopus 로고    scopus 로고
    • Dose requirement and prolactin elevation of antipsychotics in male and female patients with schizophrenia or related psychoses
    • K. Melkersson, A.L. Hulting, A. Rane Dose requirement and prolactin elevation of antipsychotics in male and female patients with schizophrenia or related psychoses Br J Clin Pharmacol 51 2001 317 324
    • (2001) Br J Clin Pharmacol , vol.51 , pp. 317-324
    • Melkersson, K.1    Hulting, A.L.2    Rane, A.3
  • 40
    • 0035031859 scopus 로고    scopus 로고
    • Duplication of CYP2D6 predicts high clearance of desipramine but high clearance does not predict duplication of CYP2D6
    • T.K. Bergmann, L. Bathum, K. Brosen Duplication of CYP2D6 predicts high clearance of desipramine but high clearance does not predict duplication of CYP2D6 Eur J Clin Pharmacol 57 2001 123 127
    • (2001) Eur J Clin Pharmacol , vol.57 , pp. 123-127
    • Bergmann, T.K.1    Bathum, L.2    Brosen, K.3
  • 41
    • 0034464046 scopus 로고    scopus 로고
    • The effect of grapefruit juice on the pharmacokinetics of erythromycin
    • S. Kanazawa, T. Ohkubo, K. Sugawara The effect of grapefruit juice on the pharmacokinetics of erythromycin Eur J Clin Pharmacol 56 2001 799 803
    • (2001) Eur J Clin Pharmacol , vol.56 , pp. 799-803
    • Kanazawa, S.1    Ohkubo, T.2    Sugawara, K.3
  • 43
    • 0035103549 scopus 로고    scopus 로고
    • Pediatric Sotalol Investigators. Pharmacokinetics and pharmacodynamics of sotalol in a pediatric population with supraventricular and ventricular tachyarrhythmia
    • J.P. Saul, B. Ross, M.S. Schaffer, L. Beemann, A.P. Melikian, J. Shi Pediatric Sotalol Investigators. Pharmacokinetics and pharmacodynamics of sotalol in a pediatric population with supraventricular and ventricular tachyarrhythmia Clin Pharmacol Ther 69 2001 145 157
    • (2001) Clin Pharmacol Ther , vol.69 , pp. 145-157
    • Saul, J.P.1    Ross, B.2    Schaffer, M.S.3    Beemann, L.4    Melikian, A.P.5    Shi, J.6
  • 45
    • 9044223023 scopus 로고
    • Annual adverse drug experience report
    • Food and Drug Administration Rockville (MD)
    • J.R. Swann, P.F. Reinstein Annual adverse drug experience report FDA report 1992 Food and Drug Administration Rockville (MD)
    • (1992) FDA Report
    • Swann, J.R.1    Reinstein, P.F.2
  • 46
    • 0031760880 scopus 로고    scopus 로고
    • Age and sex distribution of suspected adverse drug reactions to newly marketed drugs in general practice in England: Analysis of 48 cohort studies
    • R.M. Martin, P.N. Biswas, S.N. Freemantle, G.L. Pearce, R.D. Mann Age and sex distribution of suspected adverse drug reactions to newly marketed drugs in general practice in England analysis of 48 cohort studies Br J Clin Pharmacol 46 1998 505 511
    • (1998) Br J Clin Pharmacol , vol.46 , pp. 505-511
    • Martin, R.M.1    Biswas, P.N.2    Freemantle, S.N.3    Pearce, G.L.4    Mann, R.D.5
  • 48
    • 0037087563 scopus 로고    scopus 로고
    • Women experience greater toxicity with fluorouracil-based chemotherapy for colorectal cancer
    • J.A. Sloan, R.M. Goldberg, D.J. Sargent, D. Vargas-Chanes, S. Nair, S.S. Cha Women experience greater toxicity with fluorouracil-based chemotherapy for colorectal cancer J Clin Oncol 20 2002 1491 1498
    • (2002) J Clin Oncol , vol.20 , pp. 1491-1498
    • Sloan, J.A.1    Goldberg, R.M.2    Sargent, D.J.3    Vargas-Chanes, D.4    Nair, S.5    Cha, S.S.6
  • 49
    • 0034945769 scopus 로고    scopus 로고
    • Is gender a risk factor for adverse drug reactions? the example of drug-induced long QT syndrome
    • M.D. Drici, N. Clement Is gender a risk factor for adverse drug reactions? The example of drug-induced long QT syndrome Drug Saf 24 2001 575 585
    • (2001) Drug Saf , vol.24 , pp. 575-585
    • Drici, M.D.1    Clement, N.2
  • 50
    • 0033725193 scopus 로고    scopus 로고
    • Pharmacokinetic analysis of bioequivalence trials: Implications for sex-related issues in clinical pharmacology and biopharmaceutics
    • M.-L. Chen, S.-C. Lee, M.-J. Ng, D.J. Schuirmann, L.J. Lesko, R.L. Williams Pharmacokinetic analysis of bioequivalence trials implications for sex-related issues in clinical pharmacology and biopharmaceutics Clin Pharmacol Ther 68 2000 510 521
    • (2000) Clin Pharmacol Ther , vol.68 , pp. 510-521
    • Chen, M.-L.1    Lee, S.-C.2    Ng, M.-J.3    Schuirmann, D.J.4    Lesko, L.J.5    Williams, R.L.6
  • 51
    • 0037067884 scopus 로고    scopus 로고
    • Representation of the elderly, women, and minorities in heart failure clinical trials
    • A. Heiat, C.P. Gross, H.M. Krumholz Representation of the elderly, women, and minorities in heart failure clinical trials Arch Intern Med 162 2002 1682 1688
    • (2002) Arch Intern Med , vol.162 , pp. 1682-1688
    • Heiat, A.1    Gross, C.P.2    Krumholz, H.M.3
  • 52
  • 53
    • 0035827865 scopus 로고    scopus 로고
    • Representation of elderly persons and women in published randomized trials of acute coronary syndromes
    • P.Y. Lee, K.P. Alexander, B.G. Hammill, S.K. Pasquali, E.D. Peterson Representation of elderly persons and women in published randomized trials of acute coronary syndromes JAMA 286 2001 708 713
    • (2001) JAMA , vol.286 , pp. 708-713
    • Lee, P.Y.1    Alexander, K.P.2    Hammill, B.G.3    Pasquali, S.K.4    Peterson, E.D.5
  • 54
    • 2942571201 scopus 로고    scopus 로고
    • Population pharmacokinetics of pyrimethamine and sulfadoxine in children with congenital toxoplasmosis
    • T. Trenque, N. Simon, I. Villena, C. Chemla, C. Quereux, B. Leroux Population pharmacokinetics of pyrimethamine and sulfadoxine in children with congenital toxoplasmosis Br J Clin Pharmacol 57 2004 735 741
    • (2004) Br J Clin Pharmacol , vol.57 , pp. 735-741
    • Trenque, T.1    Simon, N.2    Villena, I.3    Chemla, C.4    Quereux, C.5    Leroux, B.6
  • 55
    • 1842738250 scopus 로고    scopus 로고
    • A comparison of two sparse sampling population pharmacokinetic approaches for the estimation of pharmacokinetic parameters in children
    • I. Mahmood, V. Tammara A comparison of two sparse sampling population pharmacokinetic approaches for the estimation of pharmacokinetic parameters in children Int J Clin Pharmacol Ther 42 2004 240 245
    • (2004) Int J Clin Pharmacol Ther , vol.42 , pp. 240-245
    • Mahmood, I.1    Tammara, V.2
  • 56
    • 3042653096 scopus 로고    scopus 로고
    • Clinical pharmacology: Special safety considerations in drug development and pharmacovigilance
    • K.N. Atuah, D. Hughes, M. Pirmohamed Clinical pharmacology special safety considerations in drug development and pharmacovigilance Drug Saf 27 2004 535 554
    • (2004) Drug Saf , vol.27 , pp. 535-554
    • Atuah, K.N.1    Hughes, D.2    Pirmohamed, M.3
  • 57
    • 28144449475 scopus 로고    scopus 로고
    • The University of Arizona Center for Education and Research on Therapeutics
    • The University of Arizona Center for Education and Research on Therapeutics © 2002 Arizona CERT 2005 Updated July 26, Availabe from URL: www.torsades.org. Accessed Oct 11, 2005
    • (2005) © 2002 Arizona CERT


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.