The regulatory review of radiotherapeutics: United States of America Book Section

  


Author: Lyashchenko, S. K.
Editors: Bodei, L.; Lewis, J. S.; Zeglis, B. M.
Article/Chapter Title: The regulatory review of radiotherapeutics: United States of America
Abstract: Therapeutic radiopharmaceuticals possess unique characteristics that warrant special consideration from the regulatory entities that govern the development and human use of this class of drugs. Indeed, factors such as their short shelf-life, small batch size, and emission of toxic ionizing radiation all have a major impact on the requirements governing the production, analytical testing, handling, administration, and waste management of radiotherapeutics. This chapter is intended to introduce the reader to the general regulatory landscape covering the development and clinical use of therapeutic radiopharmaceuticals in the United States of America. © The Editor(s) (if applicable) and The Author(s), under exclusive license to Springer Nature Switzerland AG 2023.
Keywords: radiopharmaceuticals; fda; radiotherapeutics; expanded access; regulations; us pharmacopeia
Book Title: Radiopharmaceutical Therapy
ISBN: 978-3-031-39004-3
Publisher: Springer  
Publication Place: Cham, Switzerland
Date Published: 2023-01-01
Start Page: 517
End Page: 521
Language: English
DOI: 10.1007/978-3-031-39005-0_25
PROVIDER: scopus
DOI/URL:

https://www.scopus.com/inward/record.uri?eid=2-s2.0-85196476895&doi=10.1007%2f978-3-031-39005-0_25&partnerID=40&md5=eaf24d03eb1dd0501f392f49beda11bb
Notes: Book chapter: 25 -- Source: Scopus
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MSK Authors
  1. Jason S Lewis
    456 Lewis
  2. Serge K. Lyashchenko
    107 Lyashchenko
  3. Lisa Bodei
    205 Bodei
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