Performance of clinical trials with radiopharmaceuticals in the United States Book Section

  


Authors: Lyashchenko, S. K.; Vietri, S. M.; Park, H. A.; Kourlas, G.
Editor: Signore, A.
Article/Chapter Title: Performance of clinical trials with radiopharmaceuticals in the United States
Abstract: Radiopharmaceuticals have gained increased clinical utility in recent years, particularly in the field of oncology. These successes have generated an un-precedented interest in clinical translation of completely novel agents, which are comprised of a variety of radionuclides and vector molecules. Due to the unique nature of radiopharmaceuticals such as short shelf life and high potency, clinical evaluations of these agents pose some challenges from the regulatory and practical point of view. The authors of this chapter provide an overview of those challenges as well as recommendations on how some of these challenges could be addressed. In particular, emphasis is placed on the description of the regulatory landscape governing the performance of clinical trials with radiopharmaceuticals in the United States, on key considerations for the operational requirements of radiopharmaceutical production facilities, and on requirements for dispensing, drug handling, and operations at the clinical site. © 2022 Elsevier Inc. All rights reserved.
Keywords: radiopharmaceuticals; radiation safety; clinical trials; clinical translation; radionuclides; dispensing; regulations; production facility; radiopharmaceutical evaluation; radiopharmacy
Book Title: Nuclear Medicine and Molecular Imaging
Volume: 1
ISBN: 978-0-12-822980-4
Publisher: Elsevier Inc.  
Publication Place: Amsterdam, Netherlands
Date Published: 2022-01-01
Start Page: 671
End Page: 677
Language: English
DOI: 10.1016/b978-0-12-822960-6.00175-7
PROVIDER: scopus
DOI/URL:

https://www.scopus.com/inward/record.uri?eid=2-s2.0-85151216860&doi=10.1016%2fB978-0-12-822960-6.00175-7&partnerID=40&md5=bfb3191b861f02a8525adbe49fa592e8
Notes: Book Chapter -- Chapter can be found within the section "Volume 1: Basic concepts, radiopharmacy and instrumentation"-- Export Date: 1 May 2023 -- Source: Scopus
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MSK Authors
  1. Serge K. Lyashchenko
    107 Lyashchenko
  2. Hijin Angela Park
    8 Park
  3. Scott M Vietri
    2 Vietri
  4. George Kourlas
    1 Kourlas
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