PK/PD
Sensitivity is needed for drug metabolism and pharmacokinetic in drug discovery
Preclinical drug metabolism, pharmacokinetic and pharmacodynamic (PK/PD) studies play a key role in lead identification and optimization. This fast-paced development process has imposed an enormous burden on the analytical scientist to design faster and more sensitive assay techniques to aid the drug discovery, development and ADME.
One example where Imperacer could face these challenges is the pharmacokinetic study of Aviscumin, a mistletoe lectin, in a pre- and phase1 clinical trial.
The presented results are part of a project for the development of an Imperacer® assay to allow for the quantification of a large number of human plasma samples obtained during the clinical trial EORTC 16002/VIS009V1.01 and to apply this method for the generation of PK/PD data in this clinical study.*
Correlation between Aviscumine dose levels and concentrations in plasma as quantified by Imperacer®. The figure shows average concentrations for patients as calculated from samples of the first (black diamonds) and a after day 39 (white squares). The inset shows the magnification of the 10–2400 ng/kg concentration range.
* Adler, M. et al. (2005) Adaptation and performance of an immuno-PCR assay for the quantification of Aviscumine in patient plasma samples.
J Pharm Biomed Anal 39, 972-82
