Monday, February 8, 2010

Selecting Health Claims for Neutraceutical Clinical Trials

Determining the primary question to be asked in a neutraceutical clinical trial is critical to its success. Ask a wrong question, design the protocol incorrectly and you end up with the wrong answer, no answer, an answer that has no market or regulatory value or even worse, negative data that stays with the neutraceutical for a lifetime.

How does one interpret R&D critical decisions regarding claim selection/definition and design a neutraceutical clinical trial that works?

Simple. Look at what happens in conventional, traditional, drug development - the regulatory process and path provides lessons for planning effective and safe neutraceutical clinical trials. As well, consider all R&D decisions from the point of view of the investigator, regulatory advisement and more importantly, the subject/patient/consumer and sponsor's interests. Follow FDA and pharma standards in clinical design and clinical conduct. Follow good clinical practice and quality control of data and documentation.

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