Harmonization of United States, European Union and Canadian First-in-Human Regulatory Requirements for Radiopharmaceuticals-Is This Possible?

Schwarz, Sally W; Decristoforo, Clemens; Goodbody, Anne E; Singhal, Nikhita; Saliba, Sarah; Ruddock, Patrick; Zukotynski, Katherine; Ross, Andrew A

Schwarz, Sally W; Decristoforo, Clemens; Goodbody, Anne E; Singhal, Nikhita; Saliba, Sarah; Ruddock, Patrick; Zukotynski, Katherine; Ross, Andrew A.

Afiliação

Schwarz SW; Washington University School of Medicine, United States.
Decristoforo C; Department of Nuclear Medicine, Medical University Insbruck, Austria.
Goodbody AE; Center for Probe Development and Commercialization, Canada.
Singhal N; McMaster University, Canada.
Saliba S; McMaster University, Canada.
Ruddock P; Center for Probe Development and Commercialization, Canada.
Zukotynski K; McMaster University, Canada.
Ross AA; Department of Diagnostic Imaging, Queen Elizabeth Health Sciences Center, Canada.

J Nucl Med ; 2018 Sep 27.

Article em En | MEDLINE | ID: mdl-30262520

Palavras-chave

Drug Safety; First-In-Man; Investigational Medicinal Product Dossier; Investigational New Drug; Molecular Imaging; Other; PET; PET/CT; PET/MRI; Radiopharmaceuticals; Research Methods; SPECT; SPECT/CT; US, EU and Canadian regulatory requirements

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Texto completo: 1 Base de dados: MEDLINE Tipo de estudo: Guideline Idioma: En Ano de publicação: 2018 Tipo de documento: Article

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Texto completo: 1 Base de dados: MEDLINE Tipo de estudo: Guideline Idioma: En Ano de publicação: 2018 Tipo de documento: Article