Clinical evaluation of therapeutic radiopharmaceuticals in oncology - Scientific guideline

The objective of this concept paper is to identify aspects that are specific for tRPs that need to be addressed in the future guideline, to complement the more general guideline on the clinical evaluation of anticancer medicinal products (EMA/CHMP/205/95 Rev.6). The scope of the guideline is to provide specific guidance on how the key concepts from the two areas of legislation should be applied to the clinical development of tRPs for marketing authorisation application.
HumanScientific guidelines

Key words: 
Therapeutic radiopharmaceuticals, marketing authorisation, dosimetry, absorbed dose, oncology, theranostics, radioligand therapy 
 

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