Pharmacogenetics and pharmacogenomics

Pharmacogenetics and Pharmacogenomics (2000) Recent Conceptual and Technical Advances. Pharmacology 61(3) (the entire issue)... 

As pharmacogenetics and pharmacogenomics are not mutually exclusive, but even sometimes display overlapping features, both disciplines are aimed at better tailoring medical therapy for a given complex disease such as essential hypertension or other CVD. In the wake of new technologies to identify candidate region for whatever phenotype, more robust and complex bioinformatic analyses are necessary to... 

There is widespread indiscriminate use of, and thus confusion about the terms pharmacogenetics and pharmacogenomics . While no universally accepted definition exists, there is emerging consensus on the differential connotation of the two terms (see Tab. 6.1). 

Rioux, P, "Clinical Trials in Pharmacogenetics and Pharmacogenomics Methods and Applications," Am. J. Health-System Pharm., 57, 887-898 (2000). 

Pharmacogenetics and Pharmacogenomics in Drug Development and Regulatory Decision-Making Report of the First FDA-PWG-PhRMA-DruSafe Workshop.199... 

Originally published by Lesko L.J., Salerno R.A., Spear B.B. et al., as Pharmacogenetics and pharmacogenomics in drug development and regulatory decision-making Report of the First FDA-PWG-PhRMA-DruSafe Workshop. ]. Clin. Pharmacol., 43, 342-358, 2003.)... 

Pharmacogenomics for Inclusion/Exclusion Criteria (or Stratification), or When Is It Appropriate for Pharmacogenetic and Pharmacogenomic Relationships to be Explored Post Hoc .210... 

Issues, limitations, and questions related to the application of pharmacogenetics and pharmacogenomics... 

There is a diversity of opinion regarding definitions and benefits of pharmacogenetics and pharmacogenomics.1 3 For example, pharmacogenetics is often considered to be the study of inter-individual variations in DNA sequence related to drug absorption and disposition (pharmacokinetics, PK) or drug action (pharmacodynamics, PD). Polymorphic variation in the genes that encode the functions of transporters,... 

Pharmacogenetics and Pharmacogenomics in Early Clinical Development (Phase I/II Trials)... 

A major goal of pharmacogenetic and pharmacogenomic analyses in early-phase clinical studies is to identify subpopulations of subjects with an improved safety and efficacy profile. However, there are various views on how pharmacogenetics and pharmacogenomics could be used in the design of clinical trials. Some examples are as follows ... 

Some believe subjects potentially at risk for adverse events or nonresponse based on prior pharmacogenetic and pharmacogenomic studies could be excluded from future studies. Others believe that because these at-risk patients may receive the drug in the real-world setting, they should be included but possibly studied in a closely monitored setting. 

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