In addition to selecting the right analyte and using the right bioanalytical assay at the required quality, taking the right samples at the right time is important to achieve valuable outcome measures like pharmacodynamic, pharmacokinetic, toxicokinetic and immunogenicity data.
Generating data that allows a good understanding of how a drug/ vaccine works and how it is handled by the body is the basis for making proper development decisions.
How we support non-/ clinical study planning
Following a proper analysis of already available data and the underlying bioanalytical assays, we assist our clients in defining their drug/ vaccine candidate selection and development studies especially with respect to any pharmacodynamic, pharmacokinetic, toxicokinetic or immunogenicity investigations. We also help identify biomarkers and biomarker sampling schedules. More precisely, our focus is on:
In vitro and in vivo studies to support drug/ vaccine candidate selection or further pharmacological profiling (potency, efficacy, pharmacokinetics, immune response parameter, pharmacodynamic biomarker)
The collection of clinical drug concentration-time data with the purpose of providing valid pharmacokinetic parameter
The design of clinical immunogenicity studies
Clinical biomarker samplings (biomarkers for mechanism of action, pharmacodynamic activity, safety, patient stratification)
Improving the basis for nonclinical and clinical decision making
In addition to assisting study planning, we help identify the adequate external partner for the conduct of non-clinical studies (PD, PK, toxicology/ toxikokinetics) and for the conduct of clinical pharmacokinetic analyses (NCA/ popPK). Further, we assist in contract negotiations and manage the outsourced activities.