Skip to main content
SpringerLink
Log in

Research and Development of New Radiopharmaceuticals

  • Chapter
  • First Online:
Radiation Physics for Nuclear Medicine

  • 2006 Accesses

Abstract

The goal of research and development (R&D) for pharmaceutical companies is to find new products, to demonstrate that these are efficacious and safe, and to get them approved by the health authorities, thus making them available for broad use by the medical community. This comprises a long chain of activities, including identification of medical needs, extensive research work, preclinical preparation for administration of the new drug to humans, and a series of clinical studies. Although this chapter focuses on R&D of radiopharmaceuticals (RPs), general aspects of R&D of (nonradioactive) pharmaceutical products are also presented. Intravenous injection is always considered as the route of administration of RPs.

This is a preview of subscription content, log in via an institution to check access.

Access this chapter

Log in via an institution
Chapter
USD 29.95
Price excludes VAT (USA)
  • Available as PDF
  • Read on any device
  • Instant download
  • Own it forever
eBook
USD 84.99
Price excludes VAT (USA)
  • Available as EPUB and PDF
  • Read on any device
  • Instant download
  • Own it forever
Softcover Book
USD 159.99
Price excludes VAT (USA)
  • Compact, lightweight edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info
Hardcover Book
USD 109.99
Price excludes VAT (USA)
  • Durable hardcover edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info

Tax calculation will be finalised at checkout

Purchases are for personal use only

Institutional subscriptions

References

  1. Laufer EM, Winkens HM, Corsten MF, Reutelingsperger CP, Narula J, Hofstra L. PET and SPECT imaging of apoptosis in vulnerable atherosclerotic plaques with radiolabeled Annexin A5. Q J Nucl Med Mol Imaging 53, 26–34 (2009).

    CAS  PubMed  Google Scholar 

  2. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research. Guidance for industry, investigators, and reviewers, exploratory IND studies (2006). http://www.fda.gov/downloads/Drugs/Guidance/-ComplianceRegulatoryInformation/Guidances/ucm078933.pdf.

  3. European Medicines Agency. ICH Topic M 3 (R2). Note for guidance on non-clinical safety studies for the conduct of human clinical trials and marketing authorization for pharmaceuticals. CPMP/ICH/286/95 (2009). http://www.ema.europa.eu/docs/en{_}GB/document{_}library/Scientific{_}guideline/2009/09/WC500002720.pdf.

  4. Kirschner AS, Ice RD, Beierwaltes WH. Radiation dosimetry of 131I-19-iodocholesterol. J Nucl Med 14, 713–717 (1973); The authors’ reply. J Nucl Med 16, 248–249 (1975).

    Google Scholar 

  5. Boxenbaum H. Interspecies scaling, allometry, physiological time, and the ground plan of pharmacokinetics. J Pharmacokinet Biopharm 10, 201–227 (1982).

    Article  CAS  PubMed  Google Scholar 

  6. O’Keefe GJ, Saunder TH, Gong SJ, Pathmaraj KU, Tochon-Danguy HJ, Villemagne VV, Krause S, Dyrks T, Dinkelborg L, Holl G, Rowe CC. Comparisons of animal human-translated and human 18F-BAY94–9172 amyloid radiation dosimetry. J Nucl Med 50 (Suppl 2), 1847 (2009).

    Google Scholar 

  7. Kolbert KS, Watson T, Matei C, Xu S, Koutcher JA, Sgouros G. Murine S factors for liver, spleen, and kidney. J Nucl Med 44, 784–791 (2003).

    Google Scholar 

  8. Franc BL, Acton PD, Mari C, Hasegawa BH. Small-animal SPECT and SPECT/CT: Important tools for preclinical investigation. J Nucl Med 49, 1651–1663 (2008).

    Google Scholar 

  9. Liang H, Yang Y, Yang K, Wu Y, Boone JM, Cherry SR. A microPET/CT system for in vivo small animal imaging. Phys Med Biol 52, 3881–3894 (2007).

    Article  CAS  PubMed  Google Scholar 

  10. Duff K, Suleman F. Transgenic mouse models of Alzheimer’s disease: how useful have they been for therapeutic development? Brief Funct Genomics Proteomics 3, 47–59 (2004).

    Article  CAS  Google Scholar 

  11. European Medicines Agency. ICH Topic E 6 (R1). Guideline for good clinical practice. Step 5. Note for guidance on good clinical practice (CPMP/ICH/135/95) (2002). http://www.ema.europa.eu/docs/en{_}GB/document{_}library/Scientific{_}guideline/2009/09/WC500002874.pdf.

  12. Zeng W. Communicating radiation exposure: a simple approach. J Nucl Med Technol 29,156–158 (2001).

    CAS  PubMed  Google Scholar 

  13. Bundesamt für Strahlenschutz [German Federal Authority for Radiation Protection]. Home page http://www.bfs.de.

  14. European system for reporting adverse reactions to and defects in radiopharmaceuticals: annual report 2000. Eur J Nucl Med 29, BP13–BP19 (2002).

    Google Scholar 

  15. Chianelli M, Mather SJ, Grossmann A, Sobnack R, Fritzberg A, Britton KE, Signore A. 99mTc-interleukin-2 scintigraphy in normal subjects and in patients with autoimmune diseases: a feasibility study. Eur J Nucl Med Mol Imaging 35, 2286–2293 (2008).

    Article  CAS  PubMed  Google Scholar 

  16. Love C, Tronco GG, Palestro CJ. Imaging of infection and inflammation with 99mTc-fanolesomab. Q J Nucl Med Mol Imaging 50, 113–120 (2006).

    CAS  PubMed  Google Scholar 

  17. Loevinger R, Budinger TF, Watson EE. MIRD primer for absorbed dose calculations. Society of Nuclear Medicine, New York. ISBN: 978-0-9320-0438-3 (1988).

    Google Scholar 

  18. International Commission on Radiological Protection. Annals of the ICRP. ICRP Publication 60. 1990 Recommendations of the ICRP. Elsevier, New York, ISBN: 978-0-08-041144-6 (1991).

    Google Scholar 

  19. International Commission on Radiological Protection. Annals of the ICRP. ICRP Publication 103. Recommendations of the ICRP. Elsevier, New York, ISBN: 978-0-7020-3048-2 (2008).

    Google Scholar 

  20. MIRD Pamphlet No. 16: Techniques for quantitative radiopharmaceutical biodistribution data acquisition and analysis for use in human radiation dose estimates. J Nucl Med 40, 37S–61S (1999).

    Google Scholar 

  21. He B, Wahl RL, Du Y, Sgouros G, Jacene H, Flinn I, Frey EC. Comparison of residence time estimation methods for radioimmunotherapy dosimetry and treatment planning – Monte Carlo simulation studies. IEEE Trans Med Imaging 27, 521–530 (2008).

    Article  CAS  PubMed  Google Scholar 

  22. Sattler B, Barthel H, Seese A, Patt M, Schildan A, Starke A, Reininger C, Rohde B, Holl G, Gertz HJ, Hegerl U, Sabri O. Radiation risk caused by [F18]Bay 94-9172, a new PET tracer for detection of cerebral β-amyloid plaques. J Nucl Med 50 (Supplement 2), 1840 (2009).

    Google Scholar 

  23. International Commission on Radiological Protection. Annals of the ICRP. ICRP Publication 23. Reference man: anatomical, physiological and metabolic characteristics. Elsevier, New York, ISBN: 978-0-08-017024-4 (1975).

    Google Scholar 

  24. O’Keefe GJ, Saunder TH, Ng S, Ackerman U, Tochon-Danguy HJ, Chan JG, Gong S, Dyrks T, Lindemann S, Holl G, Dinkelborg L, Villemagne V, Rowe CC. Radiation dosimetry ofβ-amyloid tracers 11C-PiB and 18F-BAY94-9172. J Nucl Med 50, 309–315 (2009).

    Article  PubMed  Google Scholar 

  25. Stabin MG, Sparks RB, Crowe E. OLINDA/EXM: the second-generation personal computer software for internal dose assessment in nuclear medicine. J Nucl Med 46, 1023–1027 (2005).

    PubMed  Google Scholar 

  26. Boroujerdi M. Pharmacokinetics: principles and applications. McGraw-Hill, New York, ISBN: 9780071351645 (2002).

    Google Scholar 

  27. Carson EC. Tracer kinetic modeling in PET. In: Valk PE, Bailey DL, Townsend DW, Maisey MN (editors). Positron emission tomography: basic science and clinical practice. Springer, London, 147–179. ISBN: 1 85233 798 2 (2003).

    Google Scholar 

  28. Innis RB, Cunningham VJ, Delforge J, Fujita M, Gjedde A, Gunn RN, Holden J, Houle S, Huang SC, Ichise M, Iida H, Ito H, Kimura Y, Koeppe RA, Knudsen GM, Knuuti J, Lammertsma AA, Laruelle M, Logan J, Maguire RP, Mintun MA, Morris ED, Parsey R, Price JC, Slifstein M, Sossi V, Suhara T, Votaw JR, Wong DF, Carson RE. Consensus nomenclature for in vivo imaging of reversibly binding radioligands. J Cereb Blood Flow Metab 27, 1533–1539 (2007).

    Article  CAS  PubMed  Google Scholar 

  29. Friston KF, Ashburner J, Kiebel SJ, Nichols TE, Penny WD (editors). Statistical parametric mapping: the analysis of functional brain images. Academic Press, London, ISBN: 9780123725608 (2007).

    Google Scholar 

  30. Jeong Y, Cho SS, Park JM, Kang SJ, Lee JS, Kang E, Na DL, Kim SE. 18F-FDG PET findings in frontotemporal dementia: an SPM analysis of 29 patients. J Nucl Med 46, 233–239 (2005).

    PubMed  Google Scholar 

  31. Minoshima S, Frey KA, Koeppe RA, Foster NL, Kuhl DE. A diagnostic approach in Alzheimer’s disease using three-dimensional stereotactic surface projections of fluorine-18-FDG PET. J Nucl Med 36, 1238–1248 (1995).

    CAS  PubMed  Google Scholar 

  32. Mosconi L, Tsui WH, Herholz K, Pupi A, Drezga A, Lucignani G, Reiman EM, Holthoff V, Kalbe E, Sorbi S, Diehl-Schmid J, Perneczky R, Clerici F, Caselli R, Beuthien-Baumann B, Kurz A, Minoshima S, de Leon MJ. Multicenter standardized 18F-FDG PET diagnosis of mild cognitive impairment, Alzheimer’s disease, and other dementias. J Nucl Med 49,390–398 (2008).

    Article  PubMed  Google Scholar 

  33. Rowe CC, Ackermann U, Browne W, Mulligan R, Pike KL, O’Keefe G, Tochon-Danguy H, Chan G, Berlangieri SU, Jones G, Dickinson-Rowe KL, Kung HP, Zhang W, Kung MP, Skovronsky D, Dyrks T, Holl G, Krause S, Friebe M, Lehmann L, Lindemann S, Dinkelborg LM, Masters CL, Villemagne VL. Imaging of amyloid β in Alzheimer’s disease with 18F-Bay94-9172, a novel PET tracer: proof of mechanism. Lancet Neurol 7, 129–135 (2008).

    Article  CAS  PubMed  Google Scholar 

  34. European Medicines Agency, Committee for proprietary medicinal products (CPMP). Points to consider on the evaluation of diagnostic agents, CPMP/EWP/1119/98 (2001). http://www.ema.europa.eu/docs/en{_}GB/document{_}library/Scientific{_}guideline/2009/09/WC500003655.pdf.

Download references

Author information

Authors and Affiliations

  1. Bayer Schering Pharma, Clinical Development Molecular Imaging, Berlin, Germany

    Gerhard Holl

Authors
  1. Gerhard Holl
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Gerhard Holl .

Editor information

Editors and Affiliations

  1. , Dept. of Physics, Università degli Studi di Milano, Via Celoria 16, Milano, 20133, Italy

    Marie Claire Cantone

  2. Gesundheit und Umwelt (GmbH), Helmholtz Zentrum München, Deutsches Forschungszentrum für, Ingolstädter Landstr. 1, Neuherberg, 85764, Germany

    Christoph Hoeschen

Rights and permissions

Reprints and permissions

Copyright information

© 2011 Springer Berlin Heidelberg

About this chapter

Cite this chapter

Holl, G. (2011). Research and Development of New Radiopharmaceuticals. In: Cantone, M., Hoeschen, C. (eds) Radiation Physics for Nuclear Medicine. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-642-11327-7_7

Download citation

  • DOI: https://doi.org/10.1007/978-3-642-11327-7_7

  • Published:

  • Publisher Name: Springer, Berlin, Heidelberg

  • Print ISBN: 978-3-642-11326-0

  • Online ISBN: 978-3-642-11327-7

  • eBook Packages: MedicineMedicine (R0)

Publish with us

Policies and ethics

Search

Navigation