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Pharmacogenomics and Pharmacovigilance

Nada Božina ; Medicinski fakultet Sveučilišta u Zagrebu i KBC Zagreb

Puni tekst: hrvatski pdf 218 Kb

str. 13-22

preuzimanja: 1.458


Puni tekst: engleski pdf 218 Kb

str. 13-13

preuzimanja: 338



The development of a new discipline, pharmacogenetics/pharmacogenomics, has enabled a better understanding of genetic predispositions for unexpected drug reaction developments, and consequently it improves the individualization of pharmacotherapy. There are certain genetic individual variations in metabolic and transport capacity, and thus the kinetics of drugs and other xenobiotics. In addition to adverse drug reactions (ADR) that are dose-dependent, significant ADR are mediated by immune reactions and are associated with variations in the HLA system. The individual sensitivity to the pharmacotherapy toxic effects, dependent on biotransformation processes, is associated with the genetic polymorphism of the phase I and phase II enzymes and ABC and SLC transporters. Genetic polymorphisms can also play a key role in drug interactions. Connecting pharmacogenomics to pharmacovigilance has a significant role in monitoring ADR during the post-marketing period. Regulatory authorities highlight the role and importance of genomic variability in pharmacotherapy by introducing pharmacogenomics (information on genomic markers) in the SPC. It also states into which category pharmacogenetics information belongs, whether pharmacogenetic testing is required, recommended or informative. In order to collect and implement pharmacogenomic knowledge different consortia have been established, including prestige Clinical Pharmacogenetics Implementation Consortium (CPIC), as a joint project of The Pharmacogenomics Knowledge Base (PharmGKB) and the Pharmacogenomics Research Network, which brought together eminent experts in the field of pharmacogenetics/pharmacogenomics. The main objectives of CPIC’s is to provide peer-reviewed, updated, evidence-based, freely available recommendations and guidelines for drug use according to results of pharmacogenetic analysis. These guidelines will certainly accelerate the knowledge transfer to the clinical use.

Ključne riječi

pharmacogenetics; pharmacogenomics; pharmacovigilance; adverse drug reactions; personalized medicine

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Podaci na drugim jezicima: hrvatski

Posjeta: 3.427 *