Health Canada has adopted a nonclinical safety testing guidance to help develop medication in pediatrics. This guidance called GuidanceS11: Nonclinical Safety Testing in Support of Development of Pediatric Medicines has been developed by the ICH and is slated to be implemented for September 26, 2020. It is quite likely that more studies will be needed based off of several identifying factors like younger ages of patients and the duration of the treatment.
Read more about the S11 guidance here.
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