目前用于 PET 药物的良好生产规范是什么？

What is now current good manufacturing practice for PET drugs?

机构信息

Department of Radiological Sciences, University of Oklahoma, Health Sciences Center, Oklahoma City, OK 73126-0901, USA.

出版信息

Clin Nucl Med. 2010 May;35(5):329. doi: 10.1097/RLU.0b013e3181db9d6d.

PMID:20395704

Abstract

The new CGMP for PET pharmaceuticals will significantly affect the nuclear medicine community. The documentation, and in some cases the processes for the production, quality assurance, and distribution of PET pharmaceuticals will have recommended changes. The average yearly cost of the implementation of the final rule is estimated to be about 2,450,000 dollars, not counting start-up costs.

摘要

新的 PET 药品 CGMP 将对核医学领域产生重大影响。PET 药品的生产、质量保证和分发的文件记录，以及在某些情况下的流程，都将建议进行更改。最终法规实施的平均年成本估计约为 245 万美元，不包括启动成本。