In early drug development, Synelvia proposes the following services:
Evaluation of early PK / distribution in tissues / elimination using unlabelled compounds or stable isotope labelled compounds (2H or 13C):
- Early PK in mice / rat / rabbit
- Distribution study: assay of parent compound in liver / brain / kidneys / fat
- Early PK studies in single catheterized rats / double catheterized rats
PK/PD relations in pre-clinical species:
- Early PK/PD with telemetry implanted + catheterized rats
- Early PK/PD with circulating surrogate biomarkers
- Non-invasive sampling techniques for skin / fur surface lipids collection
Lipidomics assessment for qualitative & quantitative efficacy evaluation of lipid surrogate markers in biological samples
- Fatty acids exploration in blood / tissues / skin / fur / cell cultures & supernatants
- Neutral lipids in blood / tissues / skin / fur / cell cultures & supernatants
- Eicosanoids / inflammation markers in blood / tissues / skin / cell cultures & supernatants
- Phospholipids / Ceramides in tissues / skin / cell cultures & supernatants
Evaluation of oxidative stress and inflammatory in biological samples / side-effects or efficacy POC in early development
- MDA/HNE in micro-samples of tissues / culture cells & supernatants
- 8-iso-PGF2α / 8-OHdG in urine samples / culture cells & supernatants
- NAD+/NADH in tissues / culture cells & supernatants
- Glycated compounds: HbA1c / AGEs in blood / target tissues like cornea / lens / tendons / dermis
- Antioxidative vitamins C & E analysis in tissues / culture cells & supernatants
- Mineral analysis of antioxydative minerals in tissues / culture cells & supernatants
Routine automated analysis of various biomarkers in biological samples / side-effects or efficacy POC in early development
- Proteins / enzymes
- Other biomarkers
Development & validation of analytical methods:
- Innovative approach for assay developments of protein based biomarkers (SPR / Biacore®)
- Optimisation of methods to specific biological matrices
- Sensitivity improvement of bioanalytical methods
- Precision / accuracy evaluation of methods
- Pre-analytical requirements / stability in biological matrices
- Quality control of analysis
Statistical evaluation of data / Interpretation of results
- Statistical analysis: Analysis of variance / co-variance, ACP, PLS
- Graphical / global radar explicative representations
Scientific support to product effects/ Help in decision making
Please inquire for more detailed informations in the field of early drug development.