Clinical trails at microdoses (& may be beyond) to minimize the risk both to the investor and to the patient

· TGI - Intelligence, Uncategorized

U.S. Food and Drug Administration, European Medicines Agency, and Therapeutic Goods Administration, as well as other regulatory authorities around the world recognized the phase 0 micro-dose and intravenous microtracer studies.

Captain Lawrence Xtra Gold

Micro-dose is a dose less than 0.01 of that calculated to yield phamacological effect and no greater than 100 µg. There is an increasing interest in such exploratory clinical trails since the publication of the ICH guidelines. Micro-dose (more so with  nano-dose) studies will allow earlier decision making in the drug development process and thus minimizes investment risk, late phase attrition and, time and cost of drug development.


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