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Volumn 347, Issue 18, 2002, Pages 1462-1470

Testing medications in children

(1)  Steinbrook, Robert a  

a NONE

Author keywords

[No Author keywords available]

Indexed keywords

AMLODIPINE BESYLATE; ANESTHETIC AGENT; ANTICONVULSIVE AGENT; ATORVASTATIN; AURALGAN; BETAMETHASONE DIPROPIONATE; BUSPIRONE; CORTICOSTEROID; CROMOGLYCATE DISODIUM; DIETHYLENE GLYCOL; ETODOLAC; FLUOXETINE; FLUVOXAMINE MALEATE; GABAPENTIN; HYPNOTIC SEDATIVE AGENT; LORATADINE; METFORMIN; METHYLPHENIDATE; MIDAZOLAM; OMEPRAZOLE; ORCIPRENALINE; PIMECROLIMUS; PROMETHAZINE; PROPOFOL; REBETRON; SERTRALINE; SEVOFLURANE; SULFANILAMIDE; THALIDOMIDE; UNINDEXED DRUG;

EID: 0037206361     PISSN: 00284793     EISSN: None     Source Type: Journal    
DOI: 10.1056/NEJMhpr021646     Document Type: Article
Times cited : (199)

References (57)
  • 1
    • 84942385180 scopus 로고
    • Elixir of sulfanilamide-massengill: Chemical, pharmacologic, pathologic and necropsy reports: Preliminary toxicity reports on diethylene glycol and sulfanilamide
    • Elixir of sulfanilamide-massengill: Chemical, pharmacologic, pathologic and necropsy reports: Preliminary toxicity reports on diethylene glycol and sulfanilamide. JAMA 1937;109:1531-9.
    • (1937) JAMA , vol.109 , pp. 1531-1539
  • 2
    • 84942481986 scopus 로고
    • Pathologic effects of elixir of sulfanilamide (diethylene glycol) poisoning
    • Geiling EMK, Cannon PR. Pathologic effects of elixir of sulfanilamide (diethylene glycol) poisoning. JAMA 1938;111:919-26.
    • (1938) JAMA , vol.111 , pp. 919-926
    • Geiling, E.M.K.1    Cannon, P.R.2
  • 3
    • 0002450148 scopus 로고    scopus 로고
    • Drug safety, testing, and availability, for children
    • Kauffman RE. Drug safety, testing, and availability, for children. Child Legal Rights J 1998;18(2):27-34.
    • (1998) Child Legal Rights J , vol.18 , Issue.2 , pp. 27-34
    • Kauffman, R.E.1
  • 5
    • 20244368931 scopus 로고    scopus 로고
    • Survey of unlicensed and off label drug use in paediatric wards in European countries
    • Conroy S, Choonara I, Impicciatore P, et al. Survey of unlicensed and off label drug use in paediatric wards in European countries. BMJ 2000;320:79-82.
    • (2000) BMJ , vol.320 , pp. 79-82
    • Conroy, S.1    Choonara, I.2    Impicciatore, P.3
  • 6
    • 0036607354 scopus 로고    scopus 로고
    • Off label prescribing to children in primary care in Germany: Retrospective cohort study
    • Bücheler R, Schwab M, Mörike K, et al. Off label prescribing to children in primary care in Germany: Retrospective cohort study. BMJ 2002;324:1311-2.
    • (2002) BMJ , vol.324 , pp. 1311-1312
    • Bücheler, R.1    Schwab, M.2    Mörike, K.3
  • 7
    • 0036607319 scopus 로고    scopus 로고
    • Unlicensed and offlabel drug use by children in the community: Cross sectional study
    • Schirm E, Tobi H, de Jong-van den Berg LTW. Unlicensed and offlabel drug use by children in the community: Cross sectional study. BMJ 2002;324:1312-3.
    • (2002) BMJ , vol.324 , pp. 1312-1313
    • Schirm, E.1    Tobi, H.2    De Jong-van den Berg, L.T.W.3
  • 9
    • 0005096001 scopus 로고    scopus 로고
    • Press release of the Pharmaceutical Research and Manufacturers of America, Washington, D.C., May 29
    • Survey Finds 194 Medicines in Development for Children. Press release of the Pharmaceutical Research and Manufacturers of America, Washington, D.C., May 29, 2002.
    • (2002) Survey Finds 194 Medicines in Development for Children
  • 10
    • 0005040653 scopus 로고    scopus 로고
    • Food and Drug Administration Modernization Act of 1997, Pub. L. 105-115, 105th Cong. (Nov. 21, 1997)
    • Food and Drug Administration Modernization Act of 1997, Pub. L. 105-115, 105th Cong. (Nov. 21, 1997).
  • 11
    • 0032476883 scopus 로고    scopus 로고
    • Regulations requiring manufacturers to assess the safety and effectiveness of new drugs and biological products in pediatric patients; final rule
    • Department of Health and Human Services, Food and Drug Administration. Regulations requiring manufacturers to assess the safety and effectiveness of new drugs and biological products in pediatric patients; final rule. Fed Regist 1998;63(231):66632-72.
    • (1998) Fed Regist , vol.63 , Issue.231 , pp. 66632-66672
  • 12
    • 0005009448 scopus 로고    scopus 로고
    • Association of American Physicians & Surgeons, Inc., Competitive Enterprise Institute, and Consumer Alert v. Food and Drug Administration and Department of Health and Human Services, civil action 00-02898 (U.S. D.D.C., filed Dec. 4, 2000)
    • Association of American Physicians & Surgeons, Inc., Competitive Enterprise Institute, and Consumer Alert v. Food and Drug Administration and Department of Health and Human Services, civil action 00-02898 (U.S. D.D.C., filed Dec. 4, 2000).
  • 13
    • 0002448251 scopus 로고    scopus 로고
    • FDA to suspend a rule on child drug testing: Agency says patent plan meets safety goal
    • March 19
    • Connolly C. FDA to suspend a rule on child drug testing: Agency says patent plan meets safety goal. Washington Post. March 19, 2002:A10.
    • (2002) Washington Post
    • Connolly, C.1
  • 14
    • 84993705624 scopus 로고    scopus 로고
    • The need to test drugs on children
    • April 7
    • The need to test drugs on children. New York Times. April 7, 2002(Section 4):14.
    • (2002) New York Times , Issue.SECTION 4 , pp. 14
  • 15
    • 26144458580 scopus 로고    scopus 로고
    • U.S. backs pediatric tests in reversal on drug safety
    • April 20
    • Kaufman M, Connolly C. U.S. backs pediatric tests in reversal on drug safety. Washington Post. April 20, 2002:A3.
    • (2002) Washington Post
    • Kaufman, M.1    Connolly, C.2
  • 16
    • 0005047275 scopus 로고    scopus 로고
    • Press release of the Department of Health and Human Services, Washington, D.C., April 19
    • HHS Launches New Pediatric Drug Safety Initiative. Press release of the Department of Health and Human Services, Washington, D.C., April 19, 2002.
    • (2002) HHS Launches New Pediatric Drug Safety Initiative
  • 17
    • 0034577237 scopus 로고    scopus 로고
    • The ethics of clinical trials: A child's view
    • Rosato J. The ethics of clinical trials: A child's view. J Law Med Ethics 2000;28:362-78.
    • (2000) J Law Med Ethics , vol.28 , pp. 362-378
    • Rosato, J.1
  • 18
    • 0028950350 scopus 로고
    • Guidelines for the ethical conduct of studies to evaluate drugs in pediatric populations
    • Committee on Drugs. Guidelines for the ethical conduct of studies to evaluate drugs in pediatric populations. Pediatrics 1995;95:286-94.
    • (1995) Pediatrics , vol.95 , pp. 286-294
  • 19
    • 0032887152 scopus 로고    scopus 로고
    • Lack of pediatric drug formulations
    • Nahata MC. Lack of pediatric drug formulations. Pediatrics 1999;104:Suppl:607-9.
    • (1999) Pediatrics , vol.104 , Issue.SUPPL. , pp. 607-609
    • Nahata, M.C.1
  • 20
    • 0005079528 scopus 로고    scopus 로고
    • Franklin Lakes, N.J.: Medco Health Solutions, September
    • Drug Trend Report. Franklin Lakes, N.J.: Medco Health Solutions, September 2002.
    • (2002) Drug Trend Report
  • 22
    • 0032887329 scopus 로고    scopus 로고
    • An update on the therapeutic orphan
    • Wilson JT. An update on the therapeutic orphan. Pediatrics 1999;104:Suppl:585-90.
    • (1999) Pediatrics , vol.104 , Issue.SUPPL. , pp. 585-590
    • Wilson, J.T.1
  • 23
    • 0032886474 scopus 로고    scopus 로고
    • Off-label uses of drugs in children
    • Blumer JL. Off-label uses of drugs in children. Pediatrics 1999;104:Suppl:598-602.
    • (1999) Pediatrics , vol.104 , Issue.SUPPL. , pp. 598-602
    • Blumer, J.L.1
  • 24
    • 0000211665 scopus 로고
    • Specific requirements on content and format of labeling for human prescription drugs: Revision of "pediatric use" subsection in the labeling: Final rule (21 C.F.R. part 201)
    • Department of Health and Human Services, Food and Drug Administration. Specific requirements on content and format of labeling for human prescription drugs: Revision of "pediatric use" subsection in the labeling: Final rule (21 C.F.R. part 201). Fed Regist 1994;59:64240.
    • (1994) Fed Regist , vol.59 , pp. 64240
  • 25
    • 0003999254 scopus 로고
    • Washington, D.C.: Government Printing Office. (DHEW publication no. (OS) 77-0004.)
    • National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. Research Involving Children. Washington, D.C.: Government Printing Office, 1977. (DHEW publication no. (OS) 77-0004.)
    • (1977) Research Involving Children
  • 26
    • 0028959392 scopus 로고
    • Informed consent, parental permission, and assent in pediatric practice
    • Committee on Bioethics. Informed consent, parental permission, and assent in pediatric practice. Pediatrics 1995;95:314-7.
    • (1995) Pediatrics , vol.95 , pp. 314-317
  • 27
    • 34347217456 scopus 로고
    • Protection of human subjects - Proposed regulations on research involving children
    • Department of Health, Education and Welfare. Protection of human subjects - Proposed regulations on research involving children. Fed Regist 1978;43:31786.
    • (1978) Fed Regist , vol.43 , pp. 31786
  • 28
    • 0005017837 scopus 로고    scopus 로고
    • Protection of Human Subjects, subpart D - additional protections for children involved as subjects in research, 45 C.F.R. §46.401-09
    • Protection of Human Subjects, subpart D - additional protections for children involved as subjects in research, 45 C.F.R. §46.401-09.
  • 29
    • 0000967841 scopus 로고    scopus 로고
    • Additional safeguards for children in clinical investigations of FDA-regulated products
    • Department of Health and Human Services, Food and Drug Administration. Additional safeguards for children in clinical investigations of FDA-regulated products. Fed Regist 2001;66(79):20589-600.
    • (2001) Fed Regist , vol.66 , Issue.79 , pp. 20589-20600
  • 30
    • 0037007685 scopus 로고    scopus 로고
    • Improving protection for research subjects
    • Erratum, N Engl J Med 2002;346:1838
    • Steinbrook R. Improving protection for research subjects. N Engl J Med 2002;346:1425-30. [Erratum, N Engl J Med 2002;346:1838.]
    • (2002) N Engl J Med , vol.346 , pp. 1425-1430
    • Steinbrook, R.1
  • 31
    • 0038736553 scopus 로고    scopus 로고
    • Dangerous dosage to make pediatric medicine safer, thousands of children are being used to test drugs originally designed for adults: Tragically, the side effects can sometimes prove deadly
    • February 18
    • Dembner A, Dangerous dosage to make pediatric medicine safer, thousands of children are being used to test drugs originally designed for adults: Tragically, the side effects can sometimes prove deadly. Boston Globe. February 18, 2001:A1.
    • (2001) Boston Globe
    • Dembner, A.1
  • 32
    • 0038736553 scopus 로고    scopus 로고
    • Teddy bears and veiled threats
    • March 20
    • Idem. Teddy bears and veiled threats. Boston Globe. March 20, 2001:A1.
    • (2001) Boston Globe
    • Dembner, A.1
  • 33
    • 0038736553 scopus 로고    scopus 로고
    • Who's protecting the children? Drug research raises concerns about policy and penalties
    • March 25
    • Idem. Who's protecting the children? Drug research raises concerns about policy and penalties. Boston Globe. March 25, 2001:A1.
    • (2001) Boston Globe
    • Dembner, A.1
  • 34
    • 0007596213 scopus 로고    scopus 로고
    • Children test new medicines despite doubts
    • February 11
    • Stolberg SG. Children test new medicines despite doubts. New York Times. February 11, 2001(Section 1):1.
    • (2001) New York Times , Issue.SECTION 1 , pp. 1
    • Stolberg, S.G.1
  • 35
    • 0037193702 scopus 로고    scopus 로고
    • Desperately seeking kids for clinical trials
    • May 29
    • Zimmerman R. Desperately seeking kids for clinical trials. Wall Street Journal. May 29, 2002:D1.
    • (2002) Wall Street Journal
    • Zimmerman, R.1
  • 36
    • 0005094526 scopus 로고    scopus 로고
    • Proposed recommendations regarding support of research protocol: Precursors to diabetes in Japanese American youth
    • Department of Health and Human Services. Proposed recommendations regarding support of research protocol: Precursors to diabetes in Japanese American youth. Fed Regist 2002;67(152):51283-4.
    • (2002) Fed Regist , vol.67 , Issue.152 , pp. 51283-51284
  • 38
    • 0037200115 scopus 로고    scopus 로고
    • Ethicists fault review of children's study
    • Kaiser J. Ethicists fault review of children's study. Science 2002;297:1461.
    • (2002) Science , vol.297 , pp. 1461
    • Kaiser, J.1
  • 39
    • 0029950085 scopus 로고    scopus 로고
    • Representation of African-Americans, Hispanics, and whites in National Cancer Institute cancer treatment trials
    • Tejeda HA, Green SB, Trimble EL, et al. Representation of African-Americans, Hispanics, and whites in National Cancer Institute cancer treatment trials. J Natl Cancer Inst 1996;88:812-6.
    • (1996) J Natl Cancer Inst , vol.88 , pp. 812-816
    • Tejeda, H.A.1    Green, S.B.2    Trimble, E.L.3
  • 40
    • 0005009216 scopus 로고    scopus 로고
    • Children's Health Act of 2000, Pub. L. 106-310, tit. 27, §2701, 106th Cong. (Oct. 17, 2000)
    • Children's Health Act of 2000, Pub. L. 106-310, tit. 27, §2701, 106th Cong. (Oct. 17, 2000).
  • 41
    • 0005096004 scopus 로고    scopus 로고
    • Best Pharmaceuticals for Children Act, Pub. L. 107-109, 107th Cong. (Jan. 4, 2002)
    • Best Pharmaceuticals for Children Act, Pub. L. 107-109, 107th Cong. (Jan. 4, 2002).
  • 42
    • 0005009217 scopus 로고    scopus 로고
    • Obtaining timely pediatric studies of and adequate pediatric labeling for human drugs and biologics
    • Department of Health and Human Services, Food and Drug Administration. Obtaining timely pediatric studies of and adequate pediatric labeling for human drugs and biologics. Fed Regist 2002;67(79):20070-2.
    • (2002) Fed Regist , vol.67 , Issue.79 , pp. 20070-20072
  • 43
    • 0005047278 scopus 로고    scopus 로고
    • To amend the Federal Food, Drug, and Cosmetic Act to require labeling containing information applicable to pediatric patients, S. 2394, introduced in the Senate April 29, 2002
    • To amend the Federal Food, Drug, and Cosmetic Act to require labeling containing information applicable to pediatric patients, S. 2394, introduced in the Senate April 29, 2002.
  • 44
    • 0005055383 scopus 로고    scopus 로고
    • To amend the Federal Food, Drug, and Cosmetic Act to require labeling containing information applicable to pediatric patients, H.R. 4730, introduced in the House May 14, 2002
    • To amend the Federal Food, Drug, and Cosmetic Act to require labeling containing information applicable to pediatric patients, H.R. 4730, introduced in the House May 14, 2002.
  • 48
    • 0005025104 scopus 로고    scopus 로고
    • Fairfield, Conn.: IMS Health
    • US Top 10 Products by Prescriptions. Fairfield, Conn.: IMS Health, 2002. (Accessed October 10, 2002, at http://www.imshealth.com/public/structure/dispcontent /1,2779,1343-1343-144004,00.html.)
    • (2002) US Top 10 Products by Prescriptions
  • 52
    • 4244147382 scopus 로고    scopus 로고
    • Child play: Pharmaceutical firms win big on plan to test adult drugs on kids
    • February 5
    • Zimmerman R. Child play: Pharmaceutical firms win big on plan to test adult drugs on kids. Wall Street Journal. February 5, 2001:A1.
    • (2001) Wall Street Journal
    • Zimmerman, R.1
  • 54
    • 4243949747 scopus 로고    scopus 로고
    • More accurate doses for a child's medicine
    • February 16
    • Ward R. More accurate doses for a child's medicine. Wall Street Journal. February 16, 2001:A11.
    • (2001) Wall Street Journal
    • Ward, R.1
  • 57
    • 0040622352 scopus 로고    scopus 로고
    • Center IDs top 10 drugs used off-label in out-patient setting
    • January 17. (Rockville, Md.: FDA Center for Drug Evaluation and Research.)
    • Pina LM. Center IDs top 10 drugs used off-label in out-patient setting. News Along the Pike. January 17, 1997:6-7. (Rockville, Md.: FDA Center for Drug Evaluation and Research.)
    • (1997) News Along the Pike , pp. 6-7
    • Pina, L.M.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.