Abstract
Pharmacogenetics and pharmacogenomics are two major emerging trends in medical sciences, which influence the success of drug development and therapeutics. In current times, though pharmacogenetic studies are being done extensively for research, its application for drug development needs to get started on a large scale. The major determinants of success of a new drug compound, viz safety and efficacy, have become more predictable, with the advent of pharmacogenetic studies. There is a need felt for pharmacogenomic studies, where the effects of multiple genes are assessed with the study of entire genome.Pharmacogenetic studies can be used at various stages of drug development. The effect of drug target polymorphisms on drug response can be assessed and identified. In clinical studies, pharmacogenetic tests can be used for stratification of patients based on their genotype, which corresponds to their metabolizing capacity. This prevents the occurrence of severe adverse drug reactions and helps in better outcome of clinical trials. This can also reduce attrition of drug compounds. Further, the variations in drug response can be better studied with the wider application of pharmacogenomic methods like genome wide scans, haplotype analysis and candidate gene approaches. The cost of pharmacogenetic testing has become very low, with the advent of newer high throughput genotyping systems. However, the cost of pharmacogenomic methods continues to be very high. As the treatment with several drugs is being more and more pharmacogeneticaly guided (e.g. warfarin and irinotecan), the FDA has laid down guidelines for pharmaceutical firms regarding submission of pharmacogenetic data for their drug products in labelling.
Highlights
In the process of drug discovery, most drug compounds that act on the target during the early phases fail to emerge as therapeutic agents
A classic example of genetic polymorphism affecting drug metabolism would be that of the enzyme CYP2C9, which is coded by the polymorphic gene CYP2C9
The predictability of safety and efficacy of a drug has increased to a significant level, as both are influenced by the genetic status of the individual, which can be assessed by pharmacogenetic studies
Summary
In the process of drug discovery, most drug compounds that act on the target during the early phases fail to emerge as therapeutic agents. This could be due to unexpected failure of efficacy or occurrence of adverse events. Pharmacogenetics involves the study of single gene mutations and their effect on drug response. The term pharmacogenomics is much broader and it involves surveying the entire genome to assess several determinants of drug responses.[1] The current status of pharmacogenomics is restricted to the areas of medical research and epidemiological studies. Pharmacogenetics, which is being utilised currently in therapeutics, can be utilised in drug discovery and development
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