Category Archives: Guidance

Consensus nomenclature rules for radiopharmaceutical chemistry

In 2015, a Working Group (WG) on Nomenclature in Radiopharmaceutical Chemistry and related areas was created to clarify terms and to generate consensus on the use of a standardized nomenclature in our field. This WG consists of members from several … Continue reading

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Good Practice for Introducing Radiopharmaceuticals for Clinical Use

This publication intends to provide practical support for the introduction of new radiotracers, including recommendations on the necessary steps needed to facilitate and expedite the introduction of radiopharmaceuticals in clinical use, while ensuring that a safe and high quality product … Continue reading

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EANM guideline for the preparation of an Investigational Medicinal Product Dossier

This guideline aims to take radiopharmaceutical scientists through the practicalities of preparing an Investigational Medicinal Product Dossier (IMPD), in particular giving advice where the standard format is not suitable. Examples of generic IMPDs for three classes of radiopharmaceuticals are given: … Continue reading

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Quality assurance of radiopharmaceuticals

April 2012 Joint working party of the UK Radiopharmacy Group and the NHS Pharmaceutical Quality Assurance Committee The purpose of this document is to advise all NHS and academic units that manufacture radiopharmaceuticals, and their auditors, on recommended minimum standards … Continue reading

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PET Drugs — Current Good Manufacturing Practice (CGMP)

December 2009 Guidance U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) This guidance represents the Food and Drug Administration’s (FDA’s) current thinking on this topic. It does not create or … Continue reading

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