In-vitro studies for device performance
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Hi, I wanted to ask regarding PAAB acceptability of in-vitro studies that assess device usage (e.g. in-vitro dosing performance of inhalers). I could not find any specific guidance with regard to the acceptability/study parameters for in-vitro studies. If I wanted to discuss one such study, in a branded piece focused on the device only (with a disclaimer that clinical significance is not established) would this be acceptable? Thanks in advance.
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Hi, I wanted to ask regarding PAAB acceptability of in-vitro studies that assess device usage (e.g. in-vitro dosing performance of inhalers). I could not find any specific guidance with regard to the acceptability/study parameters for in-vitro studies. If I wanted to discuss one such study, in a branded piece focused on the device only (with a disclaimer that clinical significance is not established) would this be acceptable? Thanks in advance.
Hello @mhe
This sounds like a specific question about a specific study and product. It would be difficult to speculate on the features of the study, the brand, the claim and the nature of the device. We’d suggest submitting for an opinion. In general, published, peer-reviewed, randomized control trials are required for therapeutic claims. In-vitro studies can be considered for non-clinical claims if the study is published, peer-reviewed and designed for the feature being discussed.
