Challenge: Clinical Trials in Paediatrics - ICH E11
Question Number 1
According to ICH E11 which of the following is the most important consideration in the decision to proceed with a paediatric development programme?
A
Whether there are unique paediatric indications for the product
B
The availability of alternative treatments
C
The prevalence of the indication in children
D
The presence of a serious or life-threatening disease for which the medicinal product represents a potentially important advance in therapy

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