Pharmaco-metabolomics opportunities in drug development and clinical research.

Pharmaco-metabolomics uses metabolic phenotypes for the prediction of inter-individual variations in drug response and helps in understanding the mechanisms of drug action. The field has made significant progress over the last 14 years with numerous studies providing clinical evidence for personalised medicine. However, discovered pharmaco-metabolomic biomarkers are not yet translated into clinics due to a lack of large-scale validation. Integration of targeted and untargeted metabolomics workflows into pharmacokinetic analysis and drug development can advance the field from bench to bedside. Also, Indian pharmaceutical research and its bioanalytical infrastructure are in a position to take on these opportunities by addressing challenges such as appropriate training and regulatory compliance.