Preclinical testing on animals under the strict OECD (OECD – Organisation for Economic Co-operation and Development) GLP conditions (GLP – Good Laboratory Practice) is a key and indispensable element in the development of novel pharmaceuticals. Successful completion of preclinical studies is essential prerequisite for starting Clinical trials on humans. We can realize complete preclinical studies with these substances as a one stop shop solution.
We provide standard and custom tailored studies to support CTA/MA processes and meet the needs of our clients in pharma (human and veterinary medicinal products), food, medical devices (EMA, ICH, OECD, ISO Guidelines)
Non-clinical safety studies and analytical chemistry testing can be performed under GLP requirements
Core services:
- Toxicological studies, including toxicokinetic studies and biodistribution studies (ADME) on model animals – rodents and non-rodents (mouse, rat, guinea pig, rabbit, minipig) https://fgu.cas.cz/en/departments/biological-controls
- Hematological https://fgu.cas.cz/en/departments/biological-controls and biochemical https://www.phenogenomics.cz/phenotyping/biochemistry-and-haematology/ testing of biological matrices taken from animals during toxicity studies
- Development and validation of bioanalytical methods for various test systems and biological matrices, samples measurement. https://metabolomics.fgu.cas.cz/
- Determination of metabolites in tissues and biological matrices (blood, plasma, urine, tissues) https://metabolomics.fgu.cas.cz/
- Histopathological evaluation of tissues from animals used in toxicity studies https://www.phenogenomics.cz/phenotyping/histopathology/
- PoC pharmacological studies on xenografts (on immunocompetent mice strains, as NSG, NSG-SGM3) with various cancerous cell lines, including Patient Derived Xenografts (PDX); patient derived xenografts is the area of interest, which is now being established, studies to determine therapeutic window of promising therapeutic agents. https://www.phenogenomics.cz/phenotyping/pdx-and-cancer-models/
- Whole body imaging, neurobehavioral and metabolism diagnostic tests on rodent models https://www.phenogenomics.cz/phenotyping/bioimaging-and-embryology/
- Mouse embryonal development studies of teratogenicity https://www.phenogenomics.cz/phenotyping/bioimaging-and-embryology/
- Cardiology diagnostic tests on animal models– electrocardiogram (ECG), blood pressure measurement, cardiac imaging (Echo) https://www.phenogenomics.cz/phenotyping/cardiovascular/
- Synthesis, characterization and certification of chemical substances with therapeutic potential, development of formulations for drug application (well-equipped technology lab, top chemists, complicated custom synthesis – non GMP) https://www.ibt.cas.cz/en/core-facilities/service-technology-laboratory/#about
- Consultancy services on design of preclinical activities to provide guidance to CTA