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Volumn 47, Issue 7, 2006, Pages 1220-1226

The Radioactive Drug Research Committee: Background and retrospective study of reported research data (1975-2004)

Author keywords

Basic science research; Drug quality standards; Food and Drug Administration; PET; Radiation dose limits; Radioactive Drug Research Committee; Radiolabeled drugs

Indexed keywords

CARBON 14; GALLIUM 67; IRON 52; RADIOACTIVE MATERIAL; RADIOISOTOPE; TECHNETIUM 99M; TRITIUM; NEW DRUG; RADIOPHARMACEUTICAL AGENT;

EID: 33747145288     PISSN: 01615505     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review
Times cited : (12)

References (15)
  • 1
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    • The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. 44 Federal Register 23193, April 18, 1979.
    • The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. 44 Federal Register 23193, April 18, 1979.
  • 2
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    • Declaration of Helsinki. World Medical Organization
    • Declaration of Helsinki. World Medical Organization. Br Med J. 1996;313:1448-1449.
    • (1996) Br Med J , vol.313 , pp. 1448-1449
  • 3
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    • Code of Federal Regulations Title 21, Part 312. Investigational New Drug Application. April 1, 2005
    • Code of Federal Regulations Title 21, Part 312. Investigational New Drug Application. April 1, 2005.
  • 4
    • 35148855711 scopus 로고    scopus 로고
    • Code of Federal Regulations Title 21, Part 361.1. Prescription Drugs for Human Use Generally Recognized as Safe and Effective and Not Misbranded: Drugs used in Research. April 1, 2005
    • Code of Federal Regulations Title 21, Part 361.1. Prescription Drugs for Human Use Generally Recognized as Safe and Effective and Not Misbranded: Drugs used in Research. April 1, 2005.
  • 5
    • 35148849662 scopus 로고    scopus 로고
    • Federal Register 27538-27545, July 29, 1974. Radioactive New Drugs: Radioactive Biologics Notice of Proposed Rulemaking.
    • Federal Register 27538-27545, July 29, 1974. Radioactive New Drugs: Radioactive Biologics Notice of Proposed Rulemaking.
  • 6
    • 35148841973 scopus 로고    scopus 로고
    • Federal Register 31298-31311, July 25, 1975. Radioactive New Drugs and Radioactive Biologics Termination of Exemptions.
    • Federal Register 31298-31311, July 25, 1975. Radioactive New Drugs and Radioactive Biologics Termination of Exemptions.
  • 7
    • 35148882997 scopus 로고    scopus 로고
    • Federal Register 19764-19765, April 14, 2005 (70, Number 71). Draft Guidance for Industry on Exploratory Investigational New Drugs.
    • Federal Register 19764-19765, April 14, 2005 (Volume 70, Number 71). Draft Guidance for Industry on Exploratory Investigational New Drugs.
  • 8
    • 35148856190 scopus 로고    scopus 로고
    • Federal Register 59569-59572, October 5, 2004 (69, Number 192). Radioactive Drugs for Certain Research Uses. Public Meeting.
    • Federal Register 59569-59572, October 5, 2004 (Volume 69, Number 192). Radioactive Drugs for Certain Research Uses. Public Meeting.
  • 9
    • 0032407610 scopus 로고    scopus 로고
    • Prevalence of adverse reactions to positron emitting radiopharmaceuticals in nuclear medicine
    • Silberstein EB, Saenger EL. Prevalence of adverse reactions to positron emitting radiopharmaceuticals in nuclear medicine. J Nucl Med. 1998;39:2190-2192.
    • (1998) J Nucl Med , vol.39 , pp. 2190-2192
    • Silberstein, E.B.1    Saenger, E.L.2
  • 10
    • 35148842460 scopus 로고    scopus 로고
    • Code of Federal Regulations Title 21, Part 50. Protection of Human Subjects Subpart D: Additional Safeguards for Children in Clinical Investigations. April 1, 2005
    • Code of Federal Regulations Title 21, Part 50. Protection of Human Subjects Subpart D: Additional Safeguards for Children in Clinical Investigations. April 1, 2005.
  • 11
    • 23844498764 scopus 로고    scopus 로고
    • Quantifying the federal minimal risk standard: Implications for pediatric research without a prospect of direct benefit
    • Wendler D, Belsky L, Thompson KM, Emanuel EJ. Quantifying the federal minimal risk standard: implications for pediatric research without a prospect of direct benefit. JAMA. 2005;294:826-832.
    • (2005) JAMA , vol.294 , pp. 826-832
    • Wendler, D.1    Belsky, L.2    Thompson, K.M.3    Emanuel, E.J.4
  • 12
    • 0242674706 scopus 로고    scopus 로고
    • Studies of mortality of atomic bomb survivors: Report 13 - solid cancer and noncancer mortality: 1950-1997
    • Preston DL, Shimuzu Y, Pierce DA, Suyama A, Mabuchi K. Studies of mortality of atomic bomb survivors: report 13 - solid cancer and noncancer mortality: 1950-1997. Radiat Res. 2003;160:381-407.
    • (2003) Radiat Res , vol.160 , pp. 381-407
    • Preston, D.L.1    Shimuzu, Y.2    Pierce, D.A.3    Suyama, A.4    Mabuchi, K.5
  • 13
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    • Recommendations of the International Commission on Radiological Protection: ICRP Publication 26
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    • International Commission on Radiological Protection. Recommendations of the International Commission on Radiological Protection: ICRP Publication 26. Ann ICRP. 1977;1(3):1-55.
    • (1977) Ann ICRP , vol.1 , Issue.3 , pp. 1-55
  • 14
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    • Recommendations of the International Commission on Radiological Protection: ICRP Publication 60
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    • International Commission on Radiological Protection. 1990 Recommendations of the International Commission on Radiological Protection: ICRP Publication 60. Ann ICRP. 1991;21(1-3):1-201.
    • (1990) Ann ICRP , vol.21 , Issue.1-3 , pp. 1-201
  • 15
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    • Code of Federal Regulations Title 10, Part 20. Standards for Protection Against Radiation. April 1, 2005
    • Code of Federal Regulations Title 10, Part 20. Standards for Protection Against Radiation. April 1, 2005.


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.