PEI radiopharmaceuticals in Europe: Current use and data relevant for the formulation of summaries of product characteristics (SPCs)
PEI radiopharmaceuticals in Europe: Current use and data relevant for the formulation of summaries of product characteristics (SPCs)
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DOI：
10.1007/bf01791152
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发表时间：
1995-12-01
期刊：
影响因子：
--
通讯作者：
Langstrom, B
中科院分区：
文献类型：
--
作者：
Meyer, GJ;Waters, SL;Langstrom, B
越来越多的放射性药物用于正电子发射断层扫描（PET）已经引起了监管机构的注意。为了在各方面帮助当局，EANM成立了一个PET放射性药物许可工作组；这个小组通过问卷调查了这些化合物在欧洲的使用情况。对调查表作出答复的PET中心有26个，其中包括90%以上的大型欧洲PET中心。调查显示，2-[F-18]氟-2-脱氧葡萄糖是迄今为止最重要的PET放射性药物，每周应用超过200次，其次是[O-15]水、[O-15]一氧化碳、[N-13]氨、[(11C)]- l -蛋氨酸和L-6-[F-18]氟- dopa。超过25个其他宠物经常使用放射性药物,然而,在相当低的应用频率,所使用的数据是其优先级评级的欧洲药典委员会请求专著的配方,因为集团注册可能会是宠物放射性药物,被当局起诉相关数据在毒性和剂量测定法的制定产品特征的摘要已经收集的任务组。
The increasing use of radiopharmaceuticals for positron emission tomography (PET) has come to the attention of regulatory bodies. In order to help authorities in all aspects, the EANM has formed a task group for licensing PET radiopharmaceuticals; this group has surveyed the use of these compounds in Europe by a questionnaire. The number of PET centres that responded to the questionnaire was 26, which included more than 90% of the larger European PET centres. The survey showed that 2-[F-18]fluoro-2-deoxyglucose is by far the most important PET radiopharmaceutical with more than 200 applications per week, followed by [O-15]water, [O-15]carbonmonoxide, [N-13]ammonia, [(11C)]-L-methionine, and L-6-[F-18]fluoro-DOPA. More than 25 other PET radiopharmaceuticals are in regular use, however, at rather low application frequencies, The data were used by the European Pharmacopoeia Commission for its priority rating for requesting the formulation of monographs, Since it is likely that group registrations will be is sued by authorities for the PET radiopharmaceuticals, relevant data on toxicity and dosimetry for the formulation of summaries of product characteristics have been collected by the task group as well.