PET Radiopharmaceutical Business
portes grátis
PET Radiopharmaceutical Business
An Insider's View
Salvadori, Piero A.; Pecorale, Andrea; Inzerillo, Maria Carmela
Springer International Publishing AG
02/2024
159
Dura
Inglês
9783031519079
15 a 20 dias
Descrição não disponível.
1. Management of a PET site, the ability to reach great results through a small organization.- 1.1. Differences between the management of the production of SPECT and PET radiopharmaceuticals.- 1.2. An Italian Technician in Europe and in the World: what of our way of managing the production of radiopharmaceuticals can be an excellence? When the imagination can be an advantage.- 1.3. Commercial PET, "the spider out of the hole".- 1.4. A good practice on communication to customer.- 2. PET third party collaborations.- 2.1 Development of a new tracer: connection between Research & Development (R&D) and industrial production.- 2.2. The selection of a new PET radiotracer.- 2.3. Three different manufacturing contracts with the CMO: for mature, new, investigational tracers.- 2.4. Customer order management: CMO or Corporate responsibility?.- 2.5. Collaborations with non-industrial entities (hospitals or research centers). Two different mindsets, how to reconcile them?.- 2.6. Monitoring of production and distribution reliability in a PET network.- 3. Elements to take into account for an EU PET company acquisition.- 4. An old laboratory, in the cyclotron building front lake, and its strange inhabitants.- 5. A Sustainable PET Quality Assurance (QA).- 5.1. The reasons for a choice: why working in Quality Assurance?.- 5.2. QA team of a PET site: how to do a selection for the recruitment of operational and managerial personnel.- 5.3. PET site network: skills development, relationship with management, performance monitoring.- 5.4. Organization of the QA system in a PET Pharmaceutical Facility.- 5.5. Movie or reality?.- 6. The PET manufacturing experience in a public department, a witness.- 6.1. Reasons of a decision: developing a PET radiopharmacy for internal use in a public structure.- 6.2. From a research lab (or a clinical internal service) to an industrial set up.- 6.3. From words to deeds.- 6.4. Now that you got the horse, ride it.- Conclusions.- Final Greeting.- Glossary.-Recommended readings.
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Radiolabelled Drug;Radiotracer production;Third party manufacturing;Radiopharmacy;Quality Assurance;PET radiopharmaceutical manufacturing;Radioactive drug cGMP
1. Management of a PET site, the ability to reach great results through a small organization.- 1.1. Differences between the management of the production of SPECT and PET radiopharmaceuticals.- 1.2. An Italian Technician in Europe and in the World: what of our way of managing the production of radiopharmaceuticals can be an excellence? When the imagination can be an advantage.- 1.3. Commercial PET, "the spider out of the hole".- 1.4. A good practice on communication to customer.- 2. PET third party collaborations.- 2.1 Development of a new tracer: connection between Research & Development (R&D) and industrial production.- 2.2. The selection of a new PET radiotracer.- 2.3. Three different manufacturing contracts with the CMO: for mature, new, investigational tracers.- 2.4. Customer order management: CMO or Corporate responsibility?.- 2.5. Collaborations with non-industrial entities (hospitals or research centers). Two different mindsets, how to reconcile them?.- 2.6. Monitoring of production and distribution reliability in a PET network.- 3. Elements to take into account for an EU PET company acquisition.- 4. An old laboratory, in the cyclotron building front lake, and its strange inhabitants.- 5. A Sustainable PET Quality Assurance (QA).- 5.1. The reasons for a choice: why working in Quality Assurance?.- 5.2. QA team of a PET site: how to do a selection for the recruitment of operational and managerial personnel.- 5.3. PET site network: skills development, relationship with management, performance monitoring.- 5.4. Organization of the QA system in a PET Pharmaceutical Facility.- 5.5. Movie or reality?.- 6. The PET manufacturing experience in a public department, a witness.- 6.1. Reasons of a decision: developing a PET radiopharmacy for internal use in a public structure.- 6.2. From a research lab (or a clinical internal service) to an industrial set up.- 6.3. From words to deeds.- 6.4. Now that you got the horse, ride it.- Conclusions.- Final Greeting.- Glossary.-Recommended readings.
Este título pertence ao(s) assunto(s) indicados(s). Para ver outros títulos clique no assunto desejado.
