Micro dosing (Phase 0 trials) approach has potential to reduce the number of volunteers used in research involved in the new drug development. Micro dosing is designed to speed up the development of promising drugs /imaging agents by establishing very early on whether the drug or agent behaves in human subjects as was expected from preclinical studies. It is a technique for studying the behaviour of drugs in humans through the administration of low doses (\"sub-therapeutic\") which does not produce whole-body effects, but high enough to allow study of cellular response, pharmacokinetics of the drug with almost no risk of side effects. It is a relatively recent innovation and there remains a degree of uncertainty as to whether such a small dose will adequately predict the pharmacokinetics of the therapeutically active dose. It provides early Pharmacokinetic and Pharmacodynamic information and avoids moving those drugs onto Phase 1-3. It allows selection of drug candidates more likely to be developed successfully with wide therapeutic indexes and also helps in determination of the first dose for the subsequent phase I clinical studies. The basic approach is to label a candidate drug using the radioisotope C-14 or analysis by Accelerated mass spectroscopy (AMS), Positron emission tomography (PET) and Liquid chromatography Mass spectroscopy (LC-MS).
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