Hi! I would appreciate if you can provide some clarity on why 'dosage' information is considered non-clinical (when the dosage at which a drug has established efficacy/safety is of clinical relevance). Referring to your response to Q#451, it says " A product’s Health Canada approved indication and dosing is clinically relevant" and it proceeds to say that "Although an individual product’s indication and dosing info is clinically significant, the significance of the incremental difference in indication/dosing between multiple products is generally unknown". Hence from my understanding, this is implying that when speaking of your own drug's dosage it is 'clinical' information, but when comparing dosage of products from multiple TMAs it constitutes 'non-clinical' information. Please help clarify, thank you.
M
mef
@mef
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