Author(s): Aravind Aiswarya*, V R Manohar
Micro dosing or Phase 0 clinical trial is a breakthrough in drug development, where sub therapeutic dosages of various investigational products are administered under necessary safety conditions to minimal number of volunteers in order to obtain an early pharmacokinetic profile of the product. This important important bioanlaytic tool benefits patients as well as the pharmaceutical industry by bringing out new effective molecules faster and reducing the attrition rates at later clinical trial phases. This review encompasses the concept of micro dosing from its inception to its practical approaches till date in clinical research. The concept has evolved over the last decade from merely pharmacokinetic assessments to wider perspectives like drug-drug, drug-food interactions, bioavailability, oncology, metabolic profiling and use in vulnerable populations etc. which are discussed in this article. In future, micro dosing might emerge to be the standard predictive tool for human pharmacokinetics over alternative method and may continue to provide benefits that aren’t fully realized up to date.