Pharmacokinetics/Pharmacodynamic on human clinical samples
Anti Host Cell antibodies (case study)
Circulating proteins (e.g.,cytokines, chemokines and additional auto-antibodies)
Bioanalytical Method Development and Validation
Quantitative analysis of proteins in human samples (case study) (method setup and validation, analysis) using immunoenzymatic assays.
Quantitative analysis of nucleic acids in human samples (method setup and validation, analysis) using Real time PCR.
LC-MS/MS for quantitative analysis of small molecules and peptides in human samples (method setup and validation, analysis) using SRM or MRM mode.
PK/TK and Biomarkers analyses, if required by regulatory authorities, can be performed according to GCLP and relevant ICH, EMEA, and FDA guidelines and routinely audited by our Quality Assurance Group.