Transcription of Guideline to regulations for radiopharmaceuticals in early ...
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Guideline to regulations for radiopharmaceuticals in early ...
GUIDELINESG uideline to regulations for radiopharmaceuticals in earlyphase clinical trials in the EUAlfons Verbruggen&Heinz H. Coenen&Jean-Robert Deverre&Denis Guilloteau&Bengt Langstrom&Piero A. Salvadori&Christer Halldin#EANM 2008 AbstractThe purpose of this Guideline is to help inves-tigators by giving an overview of relevant current EUrequirements concerning the quality of starting materialsand final drug products (the radiopharmaceuticals ), the non-clinical safety studies and dosimetry considerations whilstdesigning a human clinical trial which includes the use ofradiopharmaceutical Europe, radiopharmaceutical compounds are considered aspecial group of medicines. Therefore, their preparation anduse are regulated by a number of EU directives, regulationsand rules that have been adopted by member states. The rateof adoption of directives varies between countries and eachmember state may introduce changes, provided the generalscope and limits of each directive are maintained.
GUIDELINES Guideline to regulations for radiopharmaceuticals in early phase clinical trials in the EU Alfons Verbruggen & Heinz H. Coenen & Jean-Robert Deverre & Denis Guilloteau & Bengt Langstrom & Piero A. Salvadori & Christer Halldin # EANM 2008 Abstract The purpose of this guideline is to help inves-
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