放射性药物业务视角：内部观察者的眼睛看PET

English | 2024 | ISBN: 3031519078 | 275 Pages | PDF EPUB (True) | 7 MB

The book tells the reader how a niche business can develop in a complex context and a peculiar market, such as that of PET radiopharmaceuticals. The narrative gathers three different views, and allows the reader to focus on multiple aspects that may remain hidden at the beginning of a PET radiotracer project. Nevertheless, many of the considerations in the book may be useful to approach other emerging high-tech fields of biomarkers and health indicators. The successful implementation of the Quality Assurance system is a key point of a PET organization, as well as skill identification and the selection of personnel in operational and managerial duties. The development of a GMP PET manufacturing site inside a public organization from an in-house hospital radiopharmacy and the hurdles to face and become a third party site in a public-private cooperation, are detailed and commented. Finally, the book discusses how a PET site can achieve great results despite limited resources, and what are the key strategies to choose and develop new radiotracers or ensure coexistence of multiple tracers on the market. Globally, the book provides "food for thought" and may be a valuable tool for professionals in the radiopharmaceuticals industry and managers at universities or hospital willing to develop a GMP PET Production site.

这本书告诉读者如何在一个复杂背景和特殊的市场，比如PET放射性药物市场中发展一个 niche业务。叙述汇集了三种不同的观点，并允许读者关注在PET放射性示踪剂项目开始时可能会被忽略的多个方面。然而，书中许多考虑对其他新兴的生物标志物和技术领域的发展高技术领域来说也可能很有用。质量保证系统的成功实施是PET组织的关键点，同样也是识别技能和选拔运营和管理岗位人员的重要性。书中详细描述了公共机构内部医院放射性药房发展的GMP PET生产站点及其面临的挑战，成为第三方合作中的公共-私人模式的站点。最后，这本书讨论了即使资源有限，PET站点仍能取得优异成果的关键策略，以及如何选择并开发新的放射性示踪剂或确保市场上多种示踪剂共存的关键策略。全球来看，这本书提供了“养料”，对从事核药行业的人士和希望建立GMP PET生产站点的大学和医院管理人员来说，可以提供有价值的工具。

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