Question

what is the difference between regulators and biomarkers??

Answer 1

@spacemonkey Hai Sweet Friend, WeLcoMe to OpeN stuDy.. !!

Actually, There are numerous potential biomarkers that could be related to different clinical events or processes, highlighting the need for consensus among investigators and regulators on the basic principles of validating and qualifying biomarkers for decision-making.

Also, Biomarkers that will be used as surrogate endpoints (SEPs) in clinical efficacy trials or as markers of toxicity will require substantial qualification, partly because it is not self-evident what relationship exists between the effects of the drug on the biomarker and the effects of the drug on outcomes, and partly because the consequences of unreliable SEPs or toxicity biomarkers, in terms of regulatory decision-making, are much graver.

For more Information refer: article : http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2781197/

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