Tuesday, February 9, 2010

Neutraceutical - Animal Testing vs. Human Clinical Trials

Some companies may question the need for spending money on animal testing if they are committed to investing in neutraceutical clinical trials. Perhaps it is less than ethical to test neutraceuticals on animals when human research is equally possible for potentially harmless natural health products. No. There is still plenty of research that is possible only in lab animal testing and not at all in humans. For examples, where there are specific safety concerns for the neutraceutical clinical trial patient/subject and/or where the manufacturing process is likely to alter the ingredient dramatically, it is required by FDA to perform basic, extensive safety testing in animals - before marketing, before human clinical trials.

Even when animal studies are not FDA required, invitro and invivo efficacy and safety studies both offer advantages of screening several ingredients and doses of the same ingredient rapidly and more efficiently in the lab than would be possible in human clinical trials. More importantly, some animal testing models are available that can elucidate mechanisms of actions which are difficult to reveal in simple human neutraceutical clinical trials, Proof of Concept, Phase 1,2 or otherwise. As well, pharmacokinetic and bioavailability markers can be more efficiently and more effectively elucidated in animal studies.

Follow FDA, good laboratory practice, good manufacturing practice and QC when conducting animal studies. If requested by FDA, data and documentation integrity must be met.

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