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Pharmacokinetic evaluation

Pharmacokinetic evaluation

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.

We will find the right answers on your statistics questions.
Mr. Wedemeyer is at your disposal.

SocraMetrics and SocraTec R&D are officially ANVISA certified!

In November 2022 the Brazilian Agência Nacional de Vigilância Sanitária - ANVISA approved SocraTec R&D and SocraMetrics to conduct clinical trials and Data Management & Biostatistics for clinical trials, fully meeting the agency’s stringent regulations. With this certificate we will be able to help our customers achieving their goals on the Brazilian market.

We are really proud of our team and the effort everyone put into the application and inspection processes.