Drug development is tedious, cost-effective and complex process. Microdosing uses less than 1/100th of the dose calculated to yield a pharmacological effect of the test substance to a maximum dose of <100 micrograms. It helps in early pharmacokinetic evaluation of new drug molecules, which helps in the early selection of promising compounds. Unsuitable molecules can be eliminated earlier which reduces costs and avoids the unnecessary exposure of subjects in the trial to non-viable. The risk of human toxicity is less because of short duration administration. Regulatory requirements for microdosing trials are flexible and limited, which is an advantage compared to phase I. Microdosing may help both patients and the pharmaceutical industry with earlier availability of new test drugs, reduced failure of compounds at later stages and reduce the cost of drug development. This review clearly describes the role of microdosing in drug development process.
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