Production, Validation, and Exposure Dose Measurement of [<sup>13</sup>N]Ammonia Under Academic Good Manufacturing Practice Environments

Production, Validation, and Exposure Dose Measurement of [<sup>13</sup>N]Ammonia Under Academic Good Manufacturing Practice Environments

<b>Objective:</b> Current good manufacturing practice (cGMP) guidance for positron emission tomography (PET) drugs has been established in Europe and the United States. In Japan, the Pharmaceuticals and Medical Devices Agency (PMDA) approved the use of radiosynthesizers as medical device...

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Bibliographic Details
Main Authors: Katsumi Tomiyoshi, Yuta Namiki, David J. Yang, Tomio Inoue
Format: Article
Language:English
Published: MDPI AG 2025-05-01
Series:Pharmaceutics
Subjects:
[<sup>13</sup>N]NH<sub>3</sub>
production
validation
exposure rate
academic GMP
Online Access:https://www.mdpi.com/1999-4923/17/5/667
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