We are preparing a phase I clinical trial with a radiopharmaceutical and are wondering if there are specific GMP requirements ofr radiopharmaceuticals in this phase of development
Are there specific GMP requirements for radiopharmaceuticals to be used in a phase I clinical study?
Specific parts of the GMP guidelines to look at would be Annex 3 (radiopharmaceuticals) and Annex 13 (production of IMPs). I also found this publication quite helpful while preparing the quality documentation: EANM guideline for the preparation of an Investigational Medicinal Product Dossier (IMPD) | European Journal of Nuclear Medicine and Molecular Imaging
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