Quality by design (QbD) approach of pharmacogenomics in drug designing and formulation development for optimization of drug delivery systems

Conventional approaches of drug discovery are very complex, costly and time consuming. But after the completion of human genome project, applications of pharmacogenomics in this area completely revolutionize the drug discovery and development process to produce a quality by design (QbD) approach based products. The applications of two areas of pharmacogenomics i.e. structural and functional pharmacogenomics excel the drug discovery process by employing genomic data in drug target identification and evaluation, lead optimization via high throughput screening, evaluation of drug metabolizing enzymes, drug transporters and drug receptors using computer aided technique and bioinformatics library data base. Pharmacogenomics also provides an important and reliable basis for evaluation and optimization of the dosage forms as well as repositioning of failed drugs for the treatment of new disease. Various dosage forms of category of drugs such as anticancer drugs, vaccines, gene and DNA delivery systems and immunological agents can be easily evaluated based on the genetic markers of the related disease. The effect of different formulation polymers on pharmacokinetic and pharmacodynamic properties of drugs can be assessed easily and therefore it plays an important role in formulation optimization. However, current applications of pharmacogenomics in drug discovery and formulation optimization are very limited because of costly and non accessible techniques for everyone, but in future, with the advancement in the technology; the application of genomic data in drug discovery will provide us with innovative, safer and more efficacious medicines. (C) 2016 Elsevier B.V. All rights reserved.