Pharmetheus offers strategic advice and hands-on analyses across all different phases, in order to support our clients in drug development decisions. Our experienced consultants perform hands-on modeling and simulation as population PK and/or PKPD analyses, but also PBPK and NCA analyses.
At Pharmetheus, we have extensive experience in PK and PK/PD analysis to support your regulatory interactions across the product life cycle: pre-submission, during submission and in the post-authorization phase. Our way of working, with traceability and accountability from data management to report finalization, is well adapted to regulatory requirements. In fact, the structured way of reporting developed at Pharmetheus has rendered positive attention from regulatory agencies. In addition, we have former assessors of clinical pharmacology and pharmacometrics on staff that may aid in developing your regulatory strategy with respect to the clinical pharmacology package.
Pharmetheus offers physiologically based pharmacokinetic (PBPK) modeling and simulation across all phases of drug development. PBPK enables a mechanistic bottom-up modeling and simulation approach for prediction, translation and analysis of pre-clinical and clinical data. The unique palette of modeling expertise within Pharmetheus facilitates streamlined knowledge transfer of mechanistic PBPK findings to pharmacometric model development. PBPK analyses are offered adopting the modeling and simulation platform Open Systems Pharmacology Suite, which includes PK-Sim® and MoBi®. PBPK projects can be performed as stand-alone analyses or as part of a long-term clinical pharmacology strategy. Pharmetheus also provides hourly based PK-Sim® support.
In addition to the population PK and PBPK modeling work, Pharmetheus offers NCA for efficient reporting of clinical and pre-clinical study results. Pharmetheus’ Reproducible Reporting Environment enables a cost efficient analysis of excellent scientific quality.
To support the modeling activities, we have a data management team as well as QC and medical writer collaborators. Further, we are happy to provide you with expert advice on model informed drug development as well as clinical pharmacology strategies.
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