Combining strong scientific and regulatory knowledge with state-of-the art technologies, the ERBC’s analytical chemistry team conducts feasibility studies and set-up and validates new testing methods. All studies are performed in a GLP facility and clinical study samples are managed in agreement with GCP requirements (FDA and EMA guidelines).
Preclinical and clinical samples analysis
- Including logistical services
Method development/transfer and validation
- Solid phase extraction, liquid/liquid extraction, protein precipitation plate, ultra-centrifugation and micro dialysis
Microsampling plasma/blood
- Dried blood spot, volumetric blood micro extraction (VAMS), capillary micro sampling
Formulation and stability analysis
- Solutions, suspensions, diet
PK/TK samples analysis
- All biological fluids and tissues
Metabolite stability assays and identification
- High Resolution Mass Spectrometry
Oxidative metabolism
Drug- Drug Interaction studies
- Cytochrome P450 direct inhibition
- Cytochrome P450 time dependent inhibition
- Cytochrome P450 induction
Protein binding studies
Antibody studies
- PK/TK studies
- DAR characterization of ADC
Skin absorption studies (OECD 428)
Analysis of Veterinary Residues in Animal Tissues
- Solid phase and liquid-liquid extraction, protein precipitation plate
