575 - Our question is related to question no 70 which was: "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.]". PAAB answer: "The PAAB Code (s3.1.1) does not regard "review articles" as high level evidence to support a drug specific claim because they reflect an opinion/ summary from an author rather than actual findings of a primary study. This also applies to non-clinical claims. Our question: Does PAAB regard "Guidelines" (such as CGA guidelines) as high and appropriate level of evidence for a side-by-side comparison of use limitations? Thanks
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The Review Tips and Cases document “Marketing benefit claims: What are they and what level of support do they require” states that pharmacokinetic and dynamic claims should not be linked to clinical claims and should be supported by the TMA. It also states that consensus guidelines should be used for place in therapy claims. Furthermore, code section 5.10.2 states that side-by-side limitation of use presentations may be acceptable when referenced to the respective Product Monographs. The PAAB does not review guidelines as support for side-by-side comparison of product use limitations (e.g. indications, contraindications, warnings, precautions…).