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The Microdosing Concept in Clinical Trials

Clinical Research

The Microdosing Concept in Clinical Trials

Every professional in Clinical Trials will agree to the fact that clinical trials are an expensive, long and very complex activity. Sometimes it takes 10 to 15 years and billions of dollars for pharmaceutical companies to get their product marketed.  Statistics have confirmed reports that the number of molecules which enter the market to become potential drugs of the future have declined or have become static during the past 10 years. One of the main reasons of failure of drugs is during their initial development cycle wherein pre clinical studies are done on animals, prior to human trials, drug metabolism pathways may differ. To address this issue, a relatively new concept has been introduced by the name of “Microdosing” or Phase 0.

In this phase, very trace doses of the drug is administered to the human subject to obtain pharmacokinetic parameters of the drug. The concept of Microdosing can be quite useful to clinical trials. For example, during the process of drug development, there are number of molecules which have been identified having good pharmacological activity but similar or different animal pharmacokinetics, several comparative human Microdosing studies can be conducted to obtain the ultimate human pharmacokinetics. This information can be used to assist in candidate selection, to determine the probable first dose for Phase 1 study and an estimation of cost as well. Thus Microdosing is a good way to study several molecules at a time and select the best possible out of them for moving forward with Phase 1 studies.

In conclusion, it can be said the Microdosing Concept will be an acceptable concept soon and maybe eventually all clinical studies will begin with Phase 0 in the coming years

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