메뉴 건너뛰기




Volumn 6, Issue 5, 1999, Pages 263-282

Pediatric research: Coming of age in the new millennium

Author keywords

Economics of drug development; FDA final pediatric rule; FDAMA; Market exclusivity; Pediatric research capacity; Pediatric studies initiative

Indexed keywords

ARTICLE; DRUG DEVELOPMENT; DRUG EFFICACY; DRUG LABELING; DRUG SAFETY; FOOD AND DRUG ADMINISTRATION; MEDICAL RESEARCH; PEDIATRICS; PRIORITY JOURNAL;

EID: 0032878337     PISSN: 10752765     EISSN: None     Source Type: Journal    
DOI: 10.1097/00045391-199909000-00006     Document Type: Article
Times cited : (16)

References (117)
  • 1
    • 85038142352 scopus 로고    scopus 로고
    • Food and Drug Administration Modernization Act of 1997. Pub Law 105-115 (1997 Nov 21); 21 USC 355a; 111 Stat 2296
    • Food and Drug Administration Modernization Act of 1997. Pub Law 105-115 (1997 Nov 21); 21 USC 355a; 111 Stat 2296.
  • 2
    • 0000358397 scopus 로고    scopus 로고
    • Regulations requiring manufacturers to assess the safety and effectiveness of new drugs and biological products in pediatric patients
    • Regulations requiring manufacturers to assess the safety and effectiveness of new drugs and biological products in pediatric patients. Fed Reg 1998;63:66632.
    • (1998) Fed Reg , vol.63 , pp. 66632
  • 3
    • 0014244852 scopus 로고
    • Therapeutic orphans
    • Shirkey H: Therapeutic orphans. J Pediatr 1968;72:119-20.
    • (1968) J Pediatr , vol.72 , pp. 119-120
    • Shirkey, H.1
  • 5
    • 0029830349 scopus 로고    scopus 로고
    • Underserved therapeutic classes: Examples which should not be ignored in infants and children
    • Wells TG: Underserved therapeutic classes: examples which should not be ignored in infants and children. Drug Inf J 1996;30:1179.
    • (1996) Drug Inf J , vol.30 , pp. 1179
    • Wells, T.G.1
  • 6
    • 0029849222 scopus 로고    scopus 로고
    • FDA Center for Drug Evaluation and Research (CDER) pediatric plan and new regulations
    • Roberts R, Maldonado S: FDA Center for Drug Evaluation and Research (CDER) pediatric plan and new regulations. Drug Inf J 1996;30:1126.
    • (1996) Drug Inf J , vol.30 , pp. 1126
    • Roberts, R.1    Maldonado, S.2
  • 7
    • 85038144200 scopus 로고
    • Report of a workshop: Drug development and the pediatric population
    • National Academy Press, Washington, DC
    • Institute of Medicine: Report of a Workshop: Drug Development and the Pediatric Population. Forum on Drug Development, Division of Health Sciences Policy. National Academy Press, Washington, DC; 1991.
    • (1991) Forum on Drug Development, Division of Health Sciences Policy
  • 8
    • 0003636657 scopus 로고
    • Office of Technology Assessment (OTA-H-522). US GPO, Washington, DC
    • Pharmaceutical R&D Costs, Risks and Rewards. Office of Technology Assessment (OTA-H-522). US GPO, Washington, DC, 1993.
    • (1993) Pharmaceutical R&D Costs, Risks and Rewards
  • 9
    • 0038613935 scopus 로고    scopus 로고
    • Pediatric patients: Regulations requiring manufacturers to assess the safety and effectiveness of new drugs and biological products; proposed rule
    • Pediatric patients: regulations requiring manufacturers to assess the safety and effectiveness of new drugs and biological products; proposed rule. Fed Reg 1997;62: 43899.
    • (1997) Fed Reg , vol.62 , pp. 43899
  • 10
    • 0345286537 scopus 로고
    • format of labeling for human prescription drugs: Revision of "pediatric use" subsection in the labeling
    • Specific requirements on content and format of labeling for human prescription drugs: revision of "pediatric use" subsection in the labeling. Fed Reg 1994;56:64240.
    • (1994) Fed Reg , vol.56 , pp. 64240
  • 11
    • 0343426465 scopus 로고    scopus 로고
    • Pediatric drug development set for take-off
    • Wechsler J: Pediatric drug development set for take-off. Appl Clin Trials 1998;7:20.
    • (1998) Appl Clin Trials , vol.7 , pp. 20
    • Wechsler, J.1
  • 12
    • 0344855259 scopus 로고    scopus 로고
    • Proposal to test drugs in children meets resistance: Ethical concerns raised
    • Nov 30
    • Pear R: Proposal to test drugs in children meets resistance: ethical concerns raised. New York Times 1997 Nov 30:1,28.
    • (1997) New York Times , pp. 1
    • Pear, R.1
  • 13
    • 85038146185 scopus 로고    scopus 로고
    • Food and Drug Administration Modernization and Accountability Act of 1997, Senate Report 105-43, to accompany S830, Committee on Labor and Human Resources, 105th Congress, 1st Session
    • Food and Drug Administration Modernization and Accountability Act of 1997, Senate Report 105-43, to accompany S830, Committee on Labor and Human Resources, 105th Congress, 1st Session.
  • 14
    • 0344423502 scopus 로고    scopus 로고
    • FDA's paediatric list causes concern
    • FDA's paediatric list causes concern. Scrip 1998;#2340:20.
    • (1998) Scrip , vol.2340 , pp. 20
  • 16
    • 85038145808 scopus 로고    scopus 로고
    • Guidance for Industry: Qualifying for Pediatric Exclusivity Under Section 505A of the Federal Food, Drug and Cosmetic Act. Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), US Food and Drug Administration, Rockville, MD, 1998
    • Guidance for Industry: Qualifying for Pediatric Exclusivity Under Section 505A of the Federal Food, Drug and Cosmetic Act. Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), US Food and Drug Administration, Rockville, MD, 1998.
  • 18
    • 85038135261 scopus 로고    scopus 로고
    • Process for handling pediatric exclusivity
    • Center for Drug Evaluation and Research. Food and Drug Administration, Rockville, MD
    • Process for handling pediatric exclusivity. In: Manual of Policies and Procedures (MAPP), Center for Drug Evaluation and Research. Food and Drug Administration, Rockville, MD, 1998.
    • (1998) Manual of Policies and Procedures (MAPP)
  • 19
    • 85038132912 scopus 로고    scopus 로고
    • List of approved drugs for which additional pediatric information may produce health benefits in the pediatric population, May 20, 1998. Docket No. 98N-0056. Food and Drug Administration, Rockville, MD, 1998
    • List of approved drugs for which additional pediatric information may produce health benefits in the pediatric population, May 20, 1998. Docket No. 98N-0056. Food and Drug Administration, Rockville, MD, 1998.
  • 20
    • 0002152042 scopus 로고    scopus 로고
    • Survey of the pharmaceutical industry: The alchemists
    • Survey of the pharmaceutical industry: the alchemists. Economist 346:3-18.
    • Economist , vol.346 , pp. 3-18
  • 22
    • 0345286533 scopus 로고    scopus 로고
    • Antibiotic, pediatric labeling market exclusivity provisions included in House FDA reform draft bill; extension for pediatric trials is not excessive
    • Antibiotic, pediatric labeling market exclusivity provisions included in House FDA reform draft bill; extension for pediatric trials is not excessive - Hatch. Pink Sheet 1997;59:6-7.
    • (1997) Hatch. Pink Sheet , vol.59 , pp. 6-7
  • 23
    • 0345286532 scopus 로고    scopus 로고
    • Waxman/Hatch already undermined
    • Waxman/Hatch already undermined. Scrip 1998; #2310:17.
    • (1998) Scrip , vol.2310 , pp. 17
  • 24
    • 0344423497 scopus 로고    scopus 로고
    • FDAMA 'a big loss' to generics, which need help
    • FDAMA 'a big loss' to generics, which need help. Pharma Marketletter 1998;25:12-13.
    • (1998) Pharma Marketletter , vol.25 , pp. 12-13
  • 27
    • 85038132966 scopus 로고    scopus 로고
    • Pediatric formulations: A rate-limiting step
    • Drug Information Association, Arlington, VA, April 20-21
    • Nahata M: Pediatric formulations: a rate-limiting step. Presented at Pediatric Drug Development: Successes and New Solutions, Drug Information Association, Arlington, VA, April 20-21, 1998.
    • (1998) Pediatric Drug Development: Successes and New Solutions
    • Nahata, M.1
  • 28
    • 0028230667 scopus 로고
    • Drug trials in children: Ethical, legal, and practical issues
    • Kauffman RE: Drug trials in children: ethical, legal, and practical issues. J Clin Pharmacol 1994;34:296-299.
    • (1994) J Clin Pharmacol , vol.34 , pp. 296-299
    • Kauffman, R.E.1
  • 29
    • 0344855255 scopus 로고    scopus 로고
    • Sponsors send mixed message to CROs
    • Sponsors send mixed message to CROs. Center Watch 1998;5:1.
    • (1998) Center Watch , vol.5 , pp. 1
  • 30
    • 0345286529 scopus 로고    scopus 로고
    • Is outsourcing clinicel trials really more expensive?
    • Hill T, Hubbard J: Is outsourcing clinicel trials really more expensive? Scrip Magazine 1996;#44:19-20.
    • (1996) Scrip Magazine , vol.44 , pp. 19-20
    • Hill, T.1    Hubbard, J.2
  • 31
    • 0013611312 scopus 로고
    • Calculating the costs of clinical research
    • Hill T: Calculating the costs of clinical research. Scrip Magazine 1994;#22:28-30.
    • (1994) Scrip Magazine , vol.22 , pp. 28-30
    • Hill, T.1
  • 32
    • 0008887562 scopus 로고    scopus 로고
    • The little patient
    • Myshko D: The little patient. R&D Directions 1997;3: 20-26.
    • (1997) R&D Directions , vol.3 , pp. 20-26
    • Myshko, D.1
  • 34
    • 0344855255 scopus 로고    scopus 로고
    • Sponsors send mixed message to CROs
    • Sponsors send mixed message to CROs. CenterWatch 1998;5:1.
    • (1998) CenterWatch , vol.5 , pp. 1
  • 36
    • 0345286527 scopus 로고    scopus 로고
    • FDA reform must keep pace with drug research technology, Glaxo exec says
    • FDA reform must keep pace with drug research technology, Glaxo exec says. Pink Sheet 1998;60:14.
    • (1998) Pink Sheet , vol.60 , pp. 14
  • 37
    • 0344855254 scopus 로고    scopus 로고
    • Market shares shift in US sales rankings
    • Market shares shift in US sales rankings. Scrip 1998; #2314:14.
    • (1998) Scrip , vol.2314 , pp. 14
  • 41
    • 0344855253 scopus 로고    scopus 로고
    • FDA mandatory pediatric labeling rule would apply to first indication for NMEs, marketed products with wide use or important benefits for children
    • FDA mandatory pediatric labeling rule would apply to first indication for NMEs, marketed products with wide use or important benefits for children. Pink Sheet 1997;59:7.
    • (1997) Pink Sheet , vol.59 , pp. 7
  • 42
    • 0345286525 scopus 로고    scopus 로고
    • Pediatric subgroup data may be added after exclusivity filing-AAPS
    • Pediatric subgroup data may be added after exclusivity filing-AAPS. Pink Sheet 1998;60:12.
    • (1998) Pink Sheet , vol.60 , pp. 12
  • 44
    • 0345286524 scopus 로고    scopus 로고
    • Promoting pediatric and other new uses
    • Wechsler J: Promoting pediatric and other new uses. App Clin Trials 1998;7:20.
    • (1998) App Clin Trials , vol.7 , pp. 20
    • Wechsler, J.1
  • 45
    • 0030947897 scopus 로고    scopus 로고
    • The new drug approvals of 1993, 1994, and 1995: Trends in drug development
    • Kaitin K, Manocchia M: The new drug approvals of 1993, 1994, and 1995: trends in drug development. Am J Ther 1997;4:46-54.
    • (1997) Am J Ther , vol.4 , pp. 46-54
    • Kaitin, K.1    Manocchia, M.2
  • 46
    • 0030840825 scopus 로고    scopus 로고
    • Initiatives to speed new drug development and regulatory review: The impact of FDA-sponsored conferences
    • DiMasi J, Manocchia M: Initiatives to speed new drug development and regulatory review: the impact of FDA-sponsored conferences. Drug Inf J 1997;31:771-788.
    • (1997) Drug Inf J , vol.31 , pp. 771-788
    • Dimasi, J.1    Manocchia, M.2
  • 47
    • 0031894352 scopus 로고    scopus 로고
    • Faster access to drugs for serious or life-threatening illnesses through use of the accelerated approval regulation in the United States
    • Cochetto D, Jones D: Faster access to drugs for serious or life-threatening illnesses through use of the accelerated approval regulation in the United States. Drug Inf J 1998;32:27-35.
    • (1998) Drug Inf J , vol.32 , pp. 27-35
    • Cochetto, D.1    Jones, D.2
  • 48
    • 0002795885 scopus 로고    scopus 로고
    • Strategic sourcing: We're not there yet
    • Getz K: Strategic sourcing: we're not there yet. Appl Clin Trials 1998;7:40.
    • (1998) Appl Clin Trials , vol.7 , pp. 40
    • Getz, K.1
  • 49
    • 0344423490 scopus 로고    scopus 로고
    • Pharmaceutical R&D return on investment has fallen 4-5% since Waxman/Hatch - CBO draft report: Reduction in approval time worth more than patent extension
    • Pharmaceutical R&D return on investment has fallen 4-5% since Waxman/Hatch - CBO draft report: reduction in approval time worth more than patent extension. Pink Sheet 1998;60:4.
    • (1998) Pink Sheet , vol.60 , pp. 4
  • 50
    • 0344855252 scopus 로고    scopus 로고
    • FDAMA implementation to be complete within a few years, FDA's Schultz says: Agency fears that FDAMA workload will hinder ability to do other tasks
    • FDAMA implementation to be complete within a few years, FDA's Schultz says: agency fears that FDAMA workload will hinder ability to do other tasks. Pink Sheet 1998;60:7.
    • (1998) Pink Sheet , vol.60 , pp. 7
  • 51
    • 0344423489 scopus 로고    scopus 로고
    • Food/Drug Law Institute education conference
    • Food/Drug Law Institute education conference. Pharma Marketletter 1998;25:16-7.
    • (1998) Pharma Marketletter , vol.25 , pp. 16-17
  • 53
    • 0028207598 scopus 로고
    • Paediatric labeling requirements: Implications for pharmacokinetic studies
    • Wilson JT, Kearns GL, Murphy D, Yaffe SJ: Paediatric labeling requirements: implications for pharmacokinetic studies. Clin Pharmacokinet 1994;26:312.
    • (1994) Clin Pharmacokinet , vol.26 , pp. 312
    • Wilson, J.T.1    Kearns, G.L.2    Murphy, D.3    Yaffe, S.J.4
  • 55
    • 0344423487 scopus 로고    scopus 로고
    • Pediatric clinical trial length poses one problem for industry in development of data for pediatric labeling, particularly for neonates and infants, PhRMA says
    • Pediatric clinical trial length poses one problem for industry in development of data for pediatric labeling, particularly for neonates and infants, PhRMA says. Pink Sheet 1997;59:7.
    • (1997) Pink Sheet , vol.59 , pp. 7
  • 56
    • 0025284114 scopus 로고
    • Therapeutic drug monitoring in the neonate and paediatric age group: Problems and clinical pharmacokinetic implications
    • Gilman JT: Therapeutic drug monitoring in the neonate and paediatric age group: problems and clinical pharmacokinetic implications. Clin Pharmacokinet 1990;19:1-10.
    • (1990) Clin Pharmacokinet , vol.19 , pp. 1-10
    • Gilman, J.T.1
  • 57
    • 0026720072 scopus 로고
    • Pharmacokinetic studies in paediatric patients: Clinical and ethical considerations
    • Kauffman RE, Kearns GL: Pharmacokinetic studies in paediatric patients: clinical and ethical considerations. Clin Pharmacokinet 1992;23:10-29.
    • (1992) Clin Pharmacokinet , vol.23 , pp. 10-29
    • Kauffman, R.E.1    Kearns, G.L.2
  • 58
    • 0027178101 scopus 로고
    • Immunopharmacology and adverse drug reactions
    • Rieder MJ: Immunopharmacology and adverse drug reactions. J Clin Pharmacol 1993;33:316-323.
    • (1993) J Clin Pharmacol , vol.33 , pp. 316-323
    • Rieder, M.J.1
  • 59
    • 0345286520 scopus 로고    scopus 로고
    • Pharmaceutical industry pulse: Big caps and top mid/small caps look great in '98
    • Jan
    • Scala SM, Sanderson IC, Waugh JA: Pharmaceutical industry pulse: big caps and top mid/small caps look great in '98. Cowen Perspectives 1998;Jan:82.
    • (1998) Cowen Perspectives , pp. 82
    • Scala, S.M.1    Sanderson, I.C.2    Waugh, J.A.3
  • 60
    • 0344423476 scopus 로고    scopus 로고
    • Pediatric pharmacokinetic guidance awaiting policy cmte. Sign-off
    • Pediatric pharmacokinetic guidance awaiting policy cmte. sign-off. Pink Sheet 1998;60:25.
    • (1998) Pink Sheet , vol.60 , pp. 25
  • 61
    • 0345718195 scopus 로고    scopus 로고
    • PhRMA members spend $5.3 bil. On extramural R&D in 1997, survey finds
    • PhRMA members spend $5.3 bil. on extramural R&D in 1997, survey finds. Pink Sheet 1998;60:13.
    • (1998) Pink Sheet , vol.60 , pp. 13
  • 62
    • 0031951486 scopus 로고    scopus 로고
    • Pharmacogenomics: Will the regulators approve?
    • Hodgson J, Marshall A: Pharmacogenomics: will the regulators approve? Nat Biotechnol 1998;16:243-244.
    • (1998) Nat Biotechnol , vol.16 , pp. 243-244
    • Hodgson, J.1    Marshall, A.2
  • 63
    • 0029827507 scopus 로고    scopus 로고
    • Strategies for pediatric drug evaluation: A view from the trenches
    • Wilson JT: Strategies for pediatric drug evaluation: a view from the trenches. Drug Inf J 1996;30:1149-1162.
    • (1996) Drug Inf J , vol.30 , pp. 1149-1162
    • Wilson, J.T.1
  • 64
    • 0025339816 scopus 로고
    • Paediatric clinical pharmacology and the health of the world's children
    • Rieder MJ, Koren G, MacLeod SM: Paediatric clinical pharmacology and the health of the world's children. Dev Pharmacol Ther 1990;14:201-204.
    • (1990) Dev Pharmacol Ther , vol.14 , pp. 201-204
    • Rieder, M.J.1    Koren, G.2    MacLeod, S.M.3
  • 65
    • 0031006476 scopus 로고    scopus 로고
    • Opportunities in Phase IV to improve drug development
    • Woosley R: Opportunities in Phase IV to improve drug development. Food Drug Law J 1997;52:186-188.
    • (1997) Food Drug Law J , vol.52 , pp. 186-188
    • Woosley, R.1
  • 66
    • 0031827958 scopus 로고    scopus 로고
    • The impact of managed care on clinical research
    • McKee M, Mossialos E: The impact of managed care on clinical research. Pharmacoeconomics 1998;14:19-25.
    • (1998) Pharmacoeconomics , vol.14 , pp. 19-25
    • McKee, M.1    Mossialos, E.2
  • 67
    • 0345286519 scopus 로고    scopus 로고
    • U.S. National Institute of Child Health and Human Development, National Institutes of Health. NICHD, Bethesda, MD
    • A child is not just a miniature adult: Pediatric Pharmacology Research Unit Network. U.S. National Institute of Child Health and Human Development, National Institutes of Health. NICHD, Bethesda, MD, 1998.
    • (1998) A Child is Not Just a Miniature Adult: Pediatric Pharmacology Research Unit Network
  • 68
    • 85038141249 scopus 로고    scopus 로고
    • NIH policy and guidelines on the inclusion of children as participants in research involving human subjects
    • National Institutes of Health, Bethesda, MD
    • NIH policy and guidelines on the inclusion of children as participants in research involving human subjects. In: NIH Guide to Grants and Contracts. National Institutes of Health, Bethesda, MD, 1998.
    • (1998) NIH Guide to Grants and Contracts
  • 70
    • 0344893595 scopus 로고    scopus 로고
    • Labeling prescription drugs for pediatric use in the United States
    • Rogers LC, Cocchetto DM: Labeling prescription drugs for pediatric use in the United States. Appl Clin Trials 1997;6:50-56.
    • (1997) Appl Clin Trials , vol.6 , pp. 50-56
    • Rogers, L.C.1    Cocchetto, D.M.2
  • 72
    • 85038139801 scopus 로고    scopus 로고
    • Clinical trials for drug development in pediatric and adolescent patients: Potential roles for CROs and SMOs
    • Drug Information Association, Arlington VA, April 20-21
    • Keim K: Clinical trials for drug development in pediatric and adolescent patients: potential roles for CROs and SMOs. Presented at Pediatric Drug Development: Successes and New Solutions, Drug Information Association, Arlington VA, April 20-21, 1998.
    • (1998) Pediatric Drug Development: Successes and New Solutions
    • Keim, K.1
  • 74
    • 85038145762 scopus 로고    scopus 로고
    • Approved drug products to which FDA has issued a written request for pediatric studies under section 505A of the Federal Food, Drug, and Cosmetic Act. Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration, 1998
    • Approved drug products to which FDA has issued a written request for pediatric studies under section 505A of the Federal Food, Drug, and Cosmetic Act. Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration, 1998. http://www.fda.gov/ cder/pediatric/wrlist.htm.
  • 75
    • 85038137915 scopus 로고    scopus 로고
    • Pediatric regulatory initiatives: Clinical considerations: Ethical considerations, extrapolating from adult data
    • Boston, June 10
    • Botstein P: Pediatric regulatory initiatives: clinical considerations: ethical considerations, extrapolating from adult data. Presented at Drug Information Association Thirty Fourth Annual Meeting, Boston, June 10, 1998.
    • (1998) Drug Information Association Thirty Fourth Annual Meeting
    • Botstein, P.1
  • 76
    • 0025346048 scopus 로고
    • Finder's fees for research subjects
    • Lind SE: Finder's fees for research subjects. N Engl J Med 1990;323:192-195.
    • (1990) N Engl J Med , vol.323 , pp. 192-195
    • Lind, S.E.1
  • 77
    • 34548000372 scopus 로고    scopus 로고
    • USA must invest in clinical research
    • USA must invest in clinical research. Lancet 1998;351: 535.
    • (1998) Lancet , vol.351 , pp. 535
  • 78
    • 0031607976 scopus 로고    scopus 로고
    • The state of research within managed care plans: 1997 survey
    • Nelson AF, Quiter ES, Solberg LI: The state of research within managed care plans: 1997 survey. Health Affairs 1998;17:128-138.
    • (1998) Health Affairs , vol.17 , pp. 128-138
    • Nelson, A.F.1    Quiter, E.S.2    Solberg, L.I.3
  • 79
    • 0031443793 scopus 로고    scopus 로고
    • The pharmacist's duty under OBRA-90 standards
    • Brushwood DB: The pharmacist's duty under OBRA-90 standards. J Legal Med 1997;18:475-450.
    • (1997) J Legal Med , vol.18 , pp. 475-1450
    • Brushwood, D.B.1
  • 81
    • 0032546434 scopus 로고    scopus 로고
    • Psychiatric researchers under fire
    • May 19
    • Hilts PJ: Psychiatric researchers under fire. New York Times 1998 May 19;C1, C5.
    • (1998) New York Times
    • Hilts, P.J.1
  • 82
    • 0003710210 scopus 로고    scopus 로고
    • (OEI-01-97-00190) Office of the Inspector General, U.S. Department of Health and Human Services, Boston
    • Institutional review boards: their role in reviewing approved research. (OEI-01-97-00190) Office of the Inspector General, U.S. Department of Health and Human Services, Boston, 1998.
    • (1998) Institutional Review Boards: Their Role in Reviewing Approved Research
  • 83
    • 0344855248 scopus 로고    scopus 로고
    • Study finds risks to patients in drug trials: Inspector General calls supervision by review boards inadequate
    • May 30
    • Pear R: Study finds risks to patients in drug trials: Inspector General calls supervision by review boards inadequate. New York Times 1998 May 30:A9.
    • (1998) New York Times
    • Pear, R.1
  • 84
    • 85038133777 scopus 로고    scopus 로고
    • Inspector General Report: IRBs can't cope
    • Usdin S: Inspector General Report: IRBs can't cope. BioCentury 1998;6:A1-A2.
    • (1998) BioCentury , vol.6
    • Usdin, S.1
  • 85
    • 0345718189 scopus 로고    scopus 로고
    • Clinical trial recruitment ads may cause misperceptions - HHS IG report
    • Clinical trial recruitment ads may cause misperceptions - HHS IG report. Pink Sheet 1998;60:29.
    • (1998) Pink Sheet , vol.60 , pp. 29
  • 86
    • 0025636378 scopus 로고
    • The adverse effects of standardless punitive damage awards on pharmaceutical development and availability
    • Kuhlik BN, Kingham RF: The adverse effects of standardless punitive damage awards on pharmaceutical development and availability. Food Drug Cosmetic Law 1990;45:693-708.
    • (1990) Food Drug Cosmetic Law , vol.45 , pp. 693-708
    • Kuhlik, B.N.1    Kingham, R.F.2
  • 87
    • 0345718187 scopus 로고    scopus 로고
    • Product liability claims arising out of new drug clinical trials
    • Blute JG, Basham SM: Product liability claims arising out of new drug clinical trials. J BioLaw Business 1998; 1:18-28.
    • (1998) J Biolaw Business , vol.1 , pp. 18-28
    • Blute, J.G.1    Basham, S.M.2
  • 88
    • 0344855247 scopus 로고    scopus 로고
    • Clinical trial computer simulation: Applications in drug development and biotechnology
    • Gauthier M, Quintero SY: Clinical trial computer simulation: applications in drug development and biotechnology. J BioLaw Business 1998;1:97-100.
    • (1998) J Biolaw Business , vol.1 , pp. 97-100
    • Gauthier, M.1    Quintero, S.Y.2
  • 89
    • 0345286524 scopus 로고    scopus 로고
    • Promoting pediatric and other new uses
    • Wechsler J: Promoting pediatric and other new uses. App Clin Trials 1998;7:18.
    • (1998) App Clin Trials , vol.7 , pp. 18
    • Wechsler, J.1
  • 90
    • 0025774760 scopus 로고
    • Clinical pharmacology and optimal therapeutics in developing countries: Aspirations and hopes of the Pediatric Clinical Pharmacology Subcommittee
    • MacLeod SM: Clinical pharmacology and optimal therapeutics in developing countries: aspirations and hopes of the Pediatric Clinical Pharmacology Subcommittee. J Clin Epidemiol 1991;44(suppl 2):89S-93S.
    • (1991) J Clin Epidemiol , vol.44 , Issue.2 SUPPL.
    • MacLeod, S.M.1
  • 91
    • 85038140021 scopus 로고    scopus 로고
    • Conference Report No. 105-399. Food and Drug Administration Modernization Act. Public Law 105-115 (1997Nov 21); USCAAN 111 Stat: 2882-4
    • Joint explanatory statement of the Committee of Conference: legislative history. Conference Report No. 105-399. Food and Drug Administration Modernization Act. Public Law 105-115 (1997Nov 21); USCAAN 111 Stat: 2882-4.
    • Joint Explanatory Statement of the Committee of Conference: Legislative History
  • 92
    • 0345718185 scopus 로고    scopus 로고
    • Citizen's petitions to list pediatric drugs will receive expedited review
    • Citizen's petitions to list pediatric drugs will receive expedited review. Pink Sheet 1998;60:23.
    • (1998) Pink Sheet , vol.60 , pp. 23
  • 93
    • 0345718186 scopus 로고    scopus 로고
    • Risky business
    • May/ Jun;4
    • Engel S: Risky business. R&D Directions 1998 May/ Jun;4:3.
    • (1998) R&D Directions , pp. 3
    • Engel, S.1
  • 94
    • 0029852060 scopus 로고    scopus 로고
    • Water under the bridge: Postmarketing concerns as related to pediatric populations
    • Sylvestri MF: Water under the bridge: postmarketing concerns as related to pediatric populations. Drug Inf J 1996;30:1163.
    • (1996) Drug Inf J , vol.30 , pp. 1163
    • Sylvestri, M.F.1
  • 95
    • 0345286515 scopus 로고    scopus 로고
    • US group petitions FDA in "inaccurate" patient info
    • US group petitions FDA in "inaccurate" patient info. Scrip 1998;#2346:14.
    • (1998) Scrip , vol.2346 , pp. 14
  • 96
    • 0345286514 scopus 로고    scopus 로고
    • Securities law reform intensifies
    • May
    • Schmickel D. Securities law reform intensifies. BIO News 1998 May:4,9.
    • (1998) BIO News , pp. 4
    • Schmickel, D.1
  • 97
    • 46149150166 scopus 로고    scopus 로고
    • Orphan drug designation process could be "template" for fast track
    • Orphan drug designation process could be "template" for fast track. Pink Sheet 1998;60:T&G-3-T&G-5.
    • (1998) Pink Sheet , vol.60
  • 99
    • 85038149612 scopus 로고    scopus 로고
    • NIH responds to the challenge: The PPRU network
    • Drug Information Association, Arlington, VA, April 20-21
    • Alexander D: NIH responds to the challenge: the PPRU network. Presented at Pediatric Drug Development: Successes and New Solutions, Drug Information Association, Arlington, VA, April 20-21, 1998.
    • (1998) Pediatric Drug Development: Successes and New Solutions
    • Alexander, D.1
  • 100
    • 0032506933 scopus 로고    scopus 로고
    • Investigational new drug applications and new drug applications
    • Feb 11
    • Investigational new drug applications and new drug applications. Federal Register 1998 Feb 11;63(28):6854.
    • (1998) Federal Register , vol.63 , Issue.28 , pp. 6854
  • 101
    • 84996159910 scopus 로고    scopus 로고
    • Industry views US FDA pediatric study plan
    • Industry views US FDA pediatric study plan. Pharma Marketletter 1998;25:13.
    • (1998) Pharma Marketletter , vol.25 , pp. 13
  • 104
    • 0344855242 scopus 로고    scopus 로고
    • Studies for kids, drugs for seniors
    • Wechsler J: Studies for kids, drugs for seniors. Appl Clin Trials 1997;6:22.
    • (1997) Appl Clin Trials , vol.6 , pp. 22
    • Wechsler, J.1
  • 105
    • 85038136157 scopus 로고    scopus 로고
    • Federal and state reimbursement for biotechnology products
    • (Eds. Jones RL, Lytton ME, et al), Massachusetts Continuing Legal Education, Inc. (MCLE), Massachusetts Bar Association, Boston Bar Association, Boston
    • Astrue MJ: Federal and state reimbursement for biotechnology products. In: Biotech '98. (Eds. Jones RL, Lytton ME, et al), Massachusetts Continuing Legal Education, Inc. (MCLE), Massachusetts Bar Association, Boston Bar Association, Boston, 1998, pp 207-208.
    • (1998) Biotech '98 , pp. 207-208
    • Astrue, M.J.1
  • 106
    • 0344423478 scopus 로고    scopus 로고
    • Prescription mandates
    • Herstek J: Prescription mandates. State Health Notes 1998;275:7.
    • (1998) State Health Notes , vol.275 , pp. 7
    • Herstek, J.1
  • 107
    • 85038144582 scopus 로고    scopus 로고
    • Medicare reimbursement issues affecting new biotechnology
    • (Eds. Jones RL, Lytton ME, et al), Massachusetts Continuing Legal Education, Inc. (MCLE), Massachusetts Bar Association, Boston Bar Association, Boston
    • Homer L: Medicare reimbursement issues affecting new biotechnology. In: Biotech '98 (Eds. Jones RL, Lytton ME, et al), Massachusetts Continuing Legal Education, Inc. (MCLE), Massachusetts Bar Association, Boston Bar Association, Boston, 1998, p 176
    • (1998) Biotech '98 , pp. 176
    • Homer, L.1
  • 108
    • 0032473506 scopus 로고    scopus 로고
    • Utah Medicaid DUR program proves effective cost-saver
    • Klink B: Utah Medicaid DUR program proves effective cost-saver. Drug Topics 1998;142:54.
    • (1998) Drug Topics , vol.142 , pp. 54
    • Klink, B.1
  • 110
    • 0344855240 scopus 로고    scopus 로고
    • "Trade-offs" common in pediatric formulations, incentives suggested - AAPS
    • 8
    • "Trade-offs" common in pediatric formulations, incentives suggested - AAPS. Pink Sheet 1998;8; 60:11.
    • (1998) Pink Sheet , vol.60 , pp. 11
  • 111
    • 0345286512 scopus 로고    scopus 로고
    • Geriatric study incentives modeled on pediatric patent extensions suggested
    • Geriatric study incentives modeled on pediatric patent extensions suggested. Pink Sheet 1998;60:11.
    • (1998) Pink Sheet , vol.60 , pp. 11
  • 112
    • 0344855239 scopus 로고    scopus 로고
    • Domestic and multinational clinical trials: Issues in design, implementation, and management for biotechnology research and product development
    • Fishbein JM, Grignolo A, Lund M: Domestic and multinational clinical trials: issues in design, implementation, and management for biotechnology research and product development. J BioLaw Business 1998;1:6-17.
    • (1998) J Biolaw Business , vol.1 , pp. 6-17
    • Fishbein, J.M.1    Grignolo, A.2    Lund, M.3
  • 113
    • 0038072684 scopus 로고    scopus 로고
    • Clinical trials: The intersection between research and medicine
    • Blatt R, Malinowski MJ: Clinical trials: the intersection between research and medicine. J BioLaw Business 1998;1:3-5.
    • (1998) J Biolaw Business , vol.1 , pp. 3-5
    • Blatt, R.1    Malinowski, M.J.2
  • 114
    • 0031284248 scopus 로고    scopus 로고
    • Harmonization in the regulation of pharmaceutical research and human rights: The need to think globally
    • Dominguez-Urban I: Harmonization in the regulation of pharmaceutical research and human rights: the need to think globally. Cornell Intl Law J 1997;30:245-286.
    • (1997) Cornell Intl Law J , vol.30 , pp. 245-286
    • Dominguez-Urban, I.1
  • 115
    • 0344855237 scopus 로고    scopus 로고
    • International Conference on Harmonization: How the United States Food and Drug Administration will proceed
    • Showalter J: International Conference on Harmonization: how the United States Food and Drug Administration will proceed. J BioLaw Business 1998;1:90-91.
    • (1998) J BioLaw Business , vol.1 , pp. 90-91
    • Showalter, J.1
  • 116
    • 85038146142 scopus 로고    scopus 로고
    • Food and Drug Administration Modernization and Accountability Act of 1997, Senate Report 105-43, to accompany S830, Committee on Labor and Human Resources, 105th Congress, 1st Session
    • Murray P: Comments. Food and Drug Administration Modernization and Accountability Act of 1997, Senate Report 105-43, to accompany S830, Committee on Labor and Human Resources, 105th Congress, 1st Session, 1997.
    • (1997) Comments
    • Murray, P.1
  • 117
    • 85038134064 scopus 로고    scopus 로고
    • National Institute of Child Health and Human Development, Pediatric Pharmacology Research Unit Network
    • National Institute of Child Health and Human Development, Pediatric Pharmacology Research Unit Network. http://www-ppru.ucsd.edu/.


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.