Thanks to a partnership with GLP-certified Analytical Laboratory, we offer bioanalytical services in qualitative and quantitative determination of drugs in biological samples, such as biological fluids (blood, serum, plasma, saliva, urine) or tissues. Analyses are performed mainly using high performance liquid chromatography coupled with mass spectrometry (microLC-MS/MS or UHPLC-MS).
The offer includes a full bioanalysis in accordance with the GLP requirements:
- development of bioanalytical methods for qualitative and quantitative determination of the drug and/or it’s metabolites in biological material
- bioanalytical method validation according to EMA or FDA guidelines
- sample preparation (including pre-treatment in place of the volunteers, if needed)
- development of an analytical report, in accordance with EMA/FDA guidelines and the customer needs
Validated Bioanalytical Methods
| Target | Matrix | Technique | Concentration range |
|---|---|---|---|
| Aniracetam | Human plasma (K2EDTA) | LC-MS/MS | 0.05–20 ng/mL |
| 4-p-Anisamidobutyric acid (metabolite of Aniracetam) | Human plasma (K2EDTA) | LC-MS/MS | 0.05–20 µg/mL |
| Anti IIa activity | Rat plasma | Chromogenic assay | 0.141–0.885 IU/mL |
| Anti IIa activity | Human plasma (sodium citrate) | Chromogenic assay | 0.0051–0.3024 IU/mL |
| Anti Xa activity | Rat plasma | Chromogenic assay | 0.166–0.997 IU/mL |
| Anti Xa activity | Human plasma (sodium citrate) | Chromogenic assay | 0.025–0.997 IU/mL |
| TFPI activity | Human plasma (sodium citrate) | Chromogenic assay | 0.020–0.200 U/mL |
| Capecitabine | Human plasma (K2EDTA) | LC-MS | 0.1–5 µg/mL |
| Cinnarizine | Human plasma (K2EDTA) | LC-MS/MS | 1 -100 ng/mL |
| Darunavir | Human plasma (K2EDTA) | LC-MS/MS | 5–10 000 ng/mL |
| Dimenhydrinate | Human plasma (K2EDTA) | LC-MS/MS | 5–10 000 ng/mL |
| Darunavir | Human plasma (K2EDTA) | LC-MS/MS | 0.1 – 50 ng/mL |
| Drotaverine | Human plasma (K2EDTA) | LC-MS | 5–1000 ng/mL |
| Hyodeoxycholic acid | Human plasma (K2EDTA) | LC-MS | 0.1–300 µg/mL |
| Hyodeoxycholic acid | Human serum (K2EDTA) | LC-MS | 0.1–300 µg/mL |
| Irinotecan | Mouse plasma | LC-MS | 50–300 ng/mL |
| 7-Ethyl-10-hydroxy-camptothecin (metabolite of Irinotecan) | Human plasma (K2EDTA) | LC-MS/MS | 5–10 000 ng/mL |
| Darunavir | Mouse plasma | LC-MS | 30–300 ng/mL |
| Lorediplon | Human plasma (Na-Heparin) | LC-MS/MS | 0.1–50 ng/mL |
| Oseltamivir | Human plasma (potassium oxalate / sodium fluoride) | LC-MS/MS | 0.5–100 ng/mL |
| Sulfadiazine | Human plasma (K2EDTA) | LC-MS | 0.075–10 µg/mL |
| Sulfadiazine | Human urine | LC-MS | 0.25–5 µg/mL |
| 3-Demethyl Thiocolchicine 3-O-β-D-Glucuronide (metabolite of Thiocolchicoside) | Human plasma (K2EDTA) | LC-MS/MS | 0.5–100 ng/mL |
| Zolpidem | Human plasma (Na-Heparin) | LC-MS/MS | 1–250 ng/mL |
Methods under development
| Target | Matrix | Technique | Concentration range |
|---|---|---|---|
| Lopinavir | Human plasma (K2EDTA) | LC-MS/MS | - |
| Cephalexin | Human plasma (potassium oxalate / sodium fluoride) | LC-MS/MS | - |
| Clomipramine | Human plasma (K2EDTA) | LC-MS/MS | - |
| Nicotine | Human plasma | LC-MS/MS | - |
