Concept paper on a guideline for allergen products development in moderate to low-sized study populations - Scientific guideline
HumanScientific guidelines
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This concept paper proposes the development of a scientific guideline for allergen products where adequate data according to existing guidelines cannot be reasonably obtained because the number of patients available for the required clinical trials is too low and for which there is no distinct regulatory guidance currently available within the EU.
Keywords: allergen product, diagnosis, treatment, clinical development programme, quality control, guidance, moderate population, low-sized population