Complete studies at international standards
Our 10-year experience allows us to approach various types of pharmacokinetic clinical studies:
- fasting or postprandial studies with single or repeated dose administration.
- steady-stade type studies for immediate or modified release medicinal products for various pharmaceutical forms (capsules, tablets, coated tablets, modified-release tablets, suspensions) and different routes of administration (oral, topical, injectable).
Within the pharmacokinetic studies, an important stage is the bioanalytical research which allows the quantification of some very low concentrations of active ingredients from various biological matrices, of the order of FemTA or picograms per mililiter.
This involves developing and validating some laborious analytical methods using last generation equipment of high precision but also an advanced specialization of the analysts, which is a feature of the centers of excellence.
In recent years, the CDE has also approached the research in the field of the studies involving pharmacodynamic evaluation applicable for testing topical medicines containing corticosteroids.
In addition to the studies on human subjects (“in vivo” studies) the CDE performs also “surrogate” studies (“in vitro” studies) which are designed to simulate the behavior of the medicines in various biological fluids.
Thus, we obtained more than 80 marketing authorizations for Antibiotice and other 40 marketing authorizations for the external customers as a result of the clinical research.