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OTC Clinical Products

The Research Challenge

Many OTC (over-the-counter) products offer clinical benefits that need to be tested objectively to meet FDA approval for labeling and product benefit advertising. A wide range of products face such requirements - pain relievers, skin care products, shampoos, vitamin and herbal supplements, and just about any product that claims a therapeutic or cosmetic benefit of one kind or another.

Product companies that make claims that are not substantiated by scientific testing risk having their products removed from the shelves by government regulators. At a less extreme level, companies that do not do quantitative testing are not able to assess how their products compare to competitors, thereby missing out on potential marketing messages highlighting proven superior performance.

Accurate, reliable and objective testing of product attributes and claims in the past required massive expenditures and large clinical trials, often beyond the budgets of smaller product companies. Studies that relied on user self-reports were prone to error and bias, and often did not meet government requirements for proof of claims.

Why Neuroscience Matters

Neuroscience offers numerous ways to test product attributes and claims - directly and objectively. Neurometric testing can focus on a specific product benefit, like pain relief or increased attention, or provide a quantitative measure of general improvement in a person's sense of emotional well-being. Tests can be designed that allow direct comparison of competing products or calibration against an objective standard or threshold of effect.

Because Lucid is a physician-led consumer testing firm, we are uniquely qualified among neurometrics providers to design and perform clinical tests that will meet or surpass FDA requirements.

How Lucid Can Help ...



 

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