The current state of quality standards for radiopharmaceuticals (RPs) for positron-emission tomography (PET) is assessed considering primarily national and global requirements for pharmacopoeial practice. The need to develop both general pharmacopoeial standards for RPs for PET and specific monographs for separate pharmaceuticals is established. Common approaches to standardization of each quality indicator are proposed considering known features of PET RPs using dosage forms for parenteral administration as examples.

中文翻译：

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正电子发射断层扫描放射性药物药典质量标准

评估正电子发射断层扫描 (PET) 的放射性药物 (RP) 质量标准的当前状态主要是考虑到国家和全球对药典实践的要求。既需要为 PET 的 RP 制定通用药典标准，也需要为单独的药物制定具体的专论。考虑到 PET RPs 的已知特征，以肠胃外给药的剂型为例，提出了标准化每个质量指标的通用方法。