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Pediatric PET Research Regulations

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Pediatric PET Imaging

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Abstract

Good intentions are necessary, but not sufficient, to conduct pediatric positron emission tomography (PET) research. This chapter provides direction to guide the process of conducting PET research in children.

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References

  1. Fostering a culture of compliance. National Institutes of Health education and outreach seminar. Pittsburgh, July 15, 2004.

    Google Scholar 

  2. Administering and overseeing clinical research. Title 45 Public welfare. Part 46 Protection of human subjects. Revised November 13, 2001. Effective December 13, 2001. Subpart A—Federal policy for the protection of human subjects. Basic DHHS policy for the protection of human research subjects. In: Fostering a Culture of Compliance. National Institutes of Health education and outreach seminar. Pittsburgh, PA, July 15, 2004. http://ohrp.osophs.dhhs.gov/humansubjects/guidance/45cfr46.htm.

  3. Fostering a culture of compliance. National Institutes of Health education and outreach seminar. Code of Federal Regulations. The common rule (Federal Regulations). Pittsburgh, PA, July 15, 2004. http://ohrp.osophs.dhhs.gov/human subjects/guidance/45cfr46.htm.

  4. Notice of public meeting—radioactive drugs for certain research uses. Radioactive Drug Research Committee (RDRC) program. Rockville, MD, November 16,2004. http://www.fda.gov/cder/regulatory/RDRC/default.htm.

  5. Agenda of public meeting—radioactive drugs for certain research uses. Radioactive Drug Research Committee (RDRC) program minutes. Rockville, MD, November 16, 2004. http://www.fda.gov/cder/meeting/clinicalresearch/default.htm.

  6. Positron emission tomography (PET) related documents. http://www.fda.gov/cder/regulatory/PET/default.htm.

  7. What information does the RDRC review? Radioactive Drug Research Committee (RDRC) program. http://www.fda.gov/cder/regulatory/RDRC/review.htm.

  8. What are the responsibilities of the RDRC? Radioactive drug research committee (RDRC) program. http://www.fda.gov/cder/regulatory/RDRC/Responsibilities.htm.

  9. http://grants.nih.gov/grants/guide/notice-files/not98–084.html.

  10. Having trouble keeping up with clinical trials? APhA-AAPM news you can use 4(2), October 28, 2004. http://www.pharmacist.com. Info-center@apha.org.

  11. Kowalsky RJ, Falen SW. Radiopharmaceuticals in Nuclear Pharmacy and Nuclear Medicine, 2nd ed. Washington, DC: APhA, 2004. http://www.Pharmacist.com/store.cfm.

    Google Scholar 

  12. Clinical evidence to help support the clinician’s skillful use of scientifically valid and evidence based information. http://Unitedhealthcarefoundation.org.ebm.html.

  13. How do I find and track bills? Health Physics News 2005;33(1):3. http://www.hps.org.

  14. FDA meeting to focus on radioactive drugs for basic research. APhAAAPM electronic newsletter. http://www.apha.net.org.

  15. Levine G, Abel N. Considerations in the assembly and submission of the physician sponsored investigational new drug application. In: Hladik WB, Saha GB, Study KT, eds. Essentials of Nuclear Medicine Science. Baltimore: Williams & Wilkins, 1987:357–386.

    Google Scholar 

  16. Pediatric drug development. http://www.fda.gov/cder/pediatrics/index.htm.

  17. NIH grants-general information glossary (NIH-grants policy statement, revised 12/01/03. In: Fostering a Culture of Compliance. National Institutes of Health education and outreach seminar. Pittsburgh, PA, July 15, 2004:6–15. http://www.grants.nih.gov/grants/terms_.htm.

  18. NIH guide: NIH policy for data and safety monitoring, release date June 10, 1998. In: Fostering a Culture of Compliance. National Institutes of Health education and outreach seminar. Pittsburgh, PA, July 15, 2004. http://grants.nih.gov/grants/guide/notice-files/not98–084.html.

  19. Administering and overseeing clinical research. Title 45 Public welfare. Part 46 Protection of human subjects. Revised November 13,2001. Effective December 13, 2001. Subpart B—additional protections for pregnant women, human fetuses and neonates involved in research. In: Fostering a Culture of Compliance. National Institutes of Health education and outreach seminar. Pittsburgh, PA, July 15, 2004. http://ohrp.osophs.dhhs.gov./humansubjects/guidance/45cfr46.htm.

  20. Administering and overseeing clinical research. Title 45 Public welfare. Part 46 Protection of human subjects. Revised November 13, 2001. Effective December 13, 2001. Subpart C—additional protections pertaining to biomedical and behavioral research involving prisoners as subjects in research. In: Fostering a Culture of Compliance. National Institutes of Health education and outreach seminar. Pittsburgh, PA. July 15, 2004. http://ohrp.osophs.dhhs.gov/humansubjects/guidance/45cfr46.htm.

  21. Administering and overseeing clinical research. Title 45 Public welfare. Part 46 Protection of human subjects. Revised November 13, 2001. Effective December 13, 2001. Subpart D—additional DHHS protections for children involved as subjects in research. In: Fostering a Culture of Compliance. National Institutes of Health education and outreach seminar. Pittsburgh, PA, July 15, 2004. http://ohrp.sosphs.dhhs.gov/humansubjects/guidance/45cfr46.htm.

  22. COX-2 inhibitors under scrutiny in wake of Rofecoxib withdrawal. APhA Drug Info Line 2004;1–2.

    Google Scholar 

  23. Food and Drug Administration Modernization Act of 1997. Title 21. Section 121. Positron emission tomography. http://www.fda.gov/cder/regulatory/Pet/petlaw.html.

  24. Radiopharmaceuticals for positron emission tomography-compounding. Chapter 823. US Pharmacopeia 20/National Formulary 25, 2002.

    Google Scholar 

  25. Update—new fludeoxyglucose F-18 injection PET drug approved in less than 6 months. http://fda.gov/cder/regulatory/pet/Fludeoxyglucose.htm.

  26. Swanson DP. Radioactive drug research committee/human use subcommittee meeting minutes. University of Pittsburgh. Pittsburgh, PA, November 17, 2004.

    Google Scholar 

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Author information

Authors and Affiliations

  1. Departments of Radiology and Pharmaceutical Sciences, University of Pittsburgh, Schools of Medicine and Pharmacy, Pittsburgh Cancer Institute, Pittsburgh, PA, 15213, USA

    Geoffrey Levine

Authors
  1. Geoffrey Levine
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Editor information

Editors and Affiliations

  1. Department of Radiology, Division Head of Nuclear Medicine, Research Institute The Hospital for Sick Children University of Toronto, Toronto, M5G 1X8, Canada

    Martin Charron MD, FRCP(C) (Professor, Head of Research for Diagnostic Imaging Senior Associate Scientist) (Professor, Head of Research for Diagnostic Imaging Senior Associate Scientist)

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© 2006 Springer Science+Business Media, Inc.

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Levine, G. (2006). Pediatric PET Research Regulations. In: Charron, M. (eds) Pediatric PET Imaging. Springer, New York, NY. https://doi.org/10.1007/0-387-34641-4_5

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  • DOI: https://doi.org/10.1007/0-387-34641-4_5

  • Publisher Name: Springer, New York, NY

  • Print ISBN: 978-0-387-28836-9

  • Online ISBN: 978-0-387-34641-0

  • eBook Packages: MedicineMedicine (R0)

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