ABSTRACT
Every individual is unique and uniqueness includes clinical, genomic and environmental information, as well as the nature of diseases, their onset, duration and response to drug treatment. Personalized medicine is an individualized therapy which takes into account the unique profiles of a single patient for optimized treatment. The discovery of genetic, genomic and clinical biomarkers have revolutionized the treatment option in the form of personalized medicine (PM) which allows us to accurately predict a person’s susceptibility/ progression of disease, the patient’s response to therapy, and maximize the therapeutic outcome in terms of low/no toxicity for a particular patient. It aims to provide right treatment, to the right patient, at the right time, at right cost. “One size does not fit all” is the prime reason for the evolution of PM, which emphasizes on genetic makeup of individuals that can be correlated with difference in drug therapy. One of the classic example include: “same symptoms, same findings, and same disease → different patient → same drug, same Dose → different effects; either therapeutic or subtherapeutic or toxic.” This reflects the need of PM for better health outcome. Information derived from genetic tests using biomarkers are used for rapid disease diagnosis, risk assessment and better clinical decision. It plays an important role in reducing/ avoiding the adverse drug reactions and optimizing drug dose by identifying drug responders and nonresponders. The review describes the human genetic variations, biomarkers, challenges, regulation, barriers and impact of personalized medicine on clinical practice.
