Pharmaceutical drugs entering the market place is a long and complex process that requires an intensive work and a multidisciplinary knowledge….In this process the preclinical and analytical unit (PCA) of ATC offers you its expertise in the preclinical studies with a wide range of in vitro and in vivo assays which are needed for the registration of your product in development.
Studies are designed according to the sponsors’ strategy and requirements as well as in accordance with the guidelines issued by the international regulatory agencies (e.g. EMEA, FDA, OECD). The regulatory studies are conducted according to GLP standards.
Analytical systems available at ATC-PCA provide key information on the absorption, distribution, metabolism, excretion and toxicological (ADMET) parameters of new chemical entity (NCE), with high quality standards.
A good knowledge of these ADMET parameters is critical in the early stages of drug development in order to focus efforts on promising compounds with the most favorable pharmacokinetic properties and to remove compounds metabolized too quickly, with a insufficient bioavailability at the site of action or inducing unexpected in vivo adverse reactions.
Pre-clinical assays offered by ATC-PCA allow you to identify and focus your efforts on compounds that have the greatest likelihood of success by evaluating parameters such as:
- Determination of the absorption/excretion potential and the transport mechanism involved;
- Evaluation of drug binding to plasma proteins and blood cells;
- Evaluation of the metabolic stability;
- Metabolites identification and resolution of their chemical structures;
- Identification of CYP and other enzymes involved in the metabolism of a given NCE;
- Determination of the main kinetic parameters of key enzymes involved in the metabolism of a given NCE;
- Study of the induction/inhibition potential of a drug (Drug-Drug Interaction) and determination of its mechanism of inhibition;
- Interspecies comparison on the main ADME parameters