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191 - I understand that a Canadian consensus guideline is an acceptable, authoritative source. Correct? If the consensus is published in a peer-reviewed journal, but it is not explicitly called a "guideline" in the title, is this acceptable? (E.g., "Canadian consensus on..." or "Canadian clinical guidance...")
• Jennifer Carroll -
131 - I have a question about the permissibility of the phrase "treatment-free" within the following context. If we are promoting a type of treatment with product X, where the patient takes product X for 2 weeks and then does not have to take the medication again until 50 weeks later (i.e. the following year), would we be allowed to say that the patient was treatment-free for those 50 weeks. Product X has a short half-life and is out of the patient's system within 24 hours so the patient would not be receiving treatment for those 50 weeks. Other treatments for the same disease are weekly or monthly, thus discussing the "treatment-free" portion of the treatment regimen is a point we would like to discuss with HCP and patients.
• Jennifer Carroll -
118 - Under what circumstances would it be acceptable to use a peer-reviewed, published study for a schedule F drug if that study uses a dosing regimen for the companion drug (always prescribed together but not subject of advertising, nor manufactured by the same company) that is inconsistent with the product monograph?
• Jennifer Carroll -
70 - The PAAB codes allows side by side comparison of non-clinical data from 2 or monographs. Would it be acceptable to use a comparative table of non-clinical data (ie. pharmacokinetics) from a review article? Extract from 5.10.2: [Information from two or more Product Monographs on products' properties7 and on instructions for use or use limitations8 may be acceptable as side-by-side presentations and in text form.]
• Jennifer Carroll -
67 - If a product has a universally-accepted trait (such as no dose adjustment, no specific drug interaction), but this is not stated specifically in the TMA, can this claim be stated? At times, some things are not specifically stated in the TMA or the TMA is not updated for a period of time. If a trait is universally-accepted, should it not be permitted to make this claim?
• Jennifer Carroll -
30 - Can risk data be presented for patients with concomitant risk factors. ie, the product is a statin that is indicated to reduce cholesterol and also CV events in patients with high cholesterol. The registration trial obviously included patients with high cholesterol and other risk factors. Can risk data be presented on patients with hypercholesterolemia and a risk factor within the registration trial?
• Jennifer Carroll