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Our Services

We aim at identifying the best approach for your questions around the analysis of PK and PK/PD data. Our services cover all stages of drug research and development. 

Preclinical

  • Review and guidance on interpretation of PK and TK data incl. non-compartmental analysis

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  • Review and guidance on interpretation of in vitro and in vivo pharmacological studies

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  • PK and PK/PD analysis incl. dose-response and mechanistic modeling

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  • PK/PD modeling-supported design of pharmacokinetic, pharmacological and toxicological studies in animals or in vitro

Translational

  • Human PK prediction and prediction of human efficacious dose & starting dose

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  • Fit-for-purpose approach: allometric scaling, in vitro-in vivo extrapolation, empirical PK and PK/PD modeling, physiology-based PK (PBPK), mechanistic PK/PD modeling

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  • Reporting for submission to regulatory authorities

Clinical

  • Pharmacometrics: population PK analysis, physiology-based PK (PBPK), PK/PD modeling

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  • Guidance on dose selection and selection of dosing regimens

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  • Clinical trial simulations

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  • Modeling analysis plan and modeling reports for submission to regulatory authorities

We help on identifying your modeling & simulation strategy during preclinical and clinical stages along the lines of model-informed drug development (MIDD). It includes PK and PD evaluation of preclinical and clinical data to guide, e.g., study design, dosing and schedule selection in animal and human, generation of an improved mode-of-action understanding, and clinical trial design. If required, we act as an integral part of your research and development team. We review and assess PK/PD data and modeling & simulation approaches for due diligences during merger & acquisition activities.​

 

We ensure high quality analyses in a timely manner using our internal standard operating procedures, peer-reviewed processes and work instructions incorporating relevant guidelines published by EMA, FDA, and ICH. For our analysis, we use software packages that are well-accepted in the modeling community and by regulatory authorities.

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