Our long-standing pharmacokinetic expertise is already incorporated into study planning - our staff have a broad repertoire ranging from classical bioavailability and bioequivalence studies, drug-drug and drug-food interaction studies to SAD and MAD studies in the early phase, including evaluation of metabolites, metabolic ratios and dose linearity/proportionality assessments. We also bring our experience to bear on specific issues, even if they are more exotic, such as GI tract absorption studies, faecal/urinary excretion studies, or phase II pharmacodynamics studies based on pharmacokinetic principles.
Our pharmacokinetic and pharmacodynamic study evaluations are based on SOP-supported and validated processes in WinNonLin, embedded in a CFR 21 Part 11 driven IT environment and design. The classical NCA is performed using precisely pre-planned processes, all relevant evaluation details are agreed with our customers in advance via the PK part of the Statistical Analysis Plan. If desired, we of course also work with the evaluation guidelines of our customers.
For more complex modeling questions, we cooperate with internationally recognized experts who allow us to adequately map your problem with the optimal method.