Genomic Study

The impact of genomic variation on drug response may require investigation in clinical studies. For genomic variation that may affect the PK of a medicinal product, clinical studies should be designed in accordance with the Guideline on the use of pharmacogenetic methodologies in the pharmacokinetic evaluation of medicinal products. Genetic ... Read More

Identification of genetic variants demands high quality genomic DNA (gDNA). Pre-analytical variations in (i) sample collection, (ii) stability, (iii) sample labelling, (iv) transport to the site of analysis, (v) tissue/sample processing and (vi) storage, should be minimized throughout the workflow to guarantee the highest possible sample quality (see guideline ICH ... Read More