The research areas pharmacogenomics and individualised pharmacotherapy are concerned with the variability of patients' drug responses that is caused by inborn genetic differences. Research in this area concentrates on expanding the knowledge of molecular, preclinical, and clinical principles in order to arrive at a personalised pharmacotherapy. The aim is to identify the exact causes for individual differences and the variability of desired drug reactions as well as of adverse reactions and interactions of medicinal products. The findings allow the development of modern and personalised treatments and lead to improvements in the patient safety of new medicinal products and therapeutic concepts.
Simone Bergner, doctorand
Karin Holz, documentalist
Richard Lux, Simone Bergner, Karin Holz, Simone Wärntges
Studies with small, specified populations are carried out prior to drug authorisation. Following market launch, use and effects of a product need to be observed in large populations including such vulnerable groups as (pregnant) women, children, elderly people. The aim of the project is to increase drug (therapy) safety by considering the following aspects: 1) exact ascertainment of the incidence of undesired drug effects, 2) detection of delayed and/or unusual drug effects, 3) evaluation of effects of co-medication, 4) assessment of consequences of overdosing, 5) proof of superiority or inferiority compared with standard therapy.
Internal and external data bases are linked and evaluated in the light of the project aims. The results obtained using pharmacoepidemiological methods are part of the pharmacovigilance data set. They shall be the basis of evidence based regulatory risk reduction measures taken for the benefit of drug (therapy) safety.
1. Strom BL, Kimmel SE, Hennessy S (Hrsg) (2012) Pharmacoepidemiology, 5. Aufl. Wiley, Chichester