PBPK-QSP

When the objective is to leverage accumulated knowledge to inform mechanistic analyses and or achieve predictions beyond observations.

PBPK-QSP Platform Scientific Lead – Erik Sjögren, Assoc. Prof., Ph.D. Principal MIDD Consultant

Way of working

At Pharmetheus, we always make an assessment from the perspectives of necessity and possibility in the design of an efficient strategy to address your current needs. This to determine how to best leverage current knowledge to reach set objectives, while keeping an eye open to future potential applications. Projects are conducted according to Pharmetheus’ way of working to ensure reproducibility and quality in deliverables of regulatory standards.  Our clients have submitted reports to the authorities with our support.

Tools

Physiologically-based pharmacokinetics-quantitative systems pharmacology (PBPK-QSP) is often associated with an expensive and closed licensed tool.

“We take a different view. the PBPK-QSP platform’s toolbox includes solutions beyond generic implementations and endorses the open science philosophy.”


In this spirit, Pharmetheus also leads its own research initiatives and collaborates with a range of subject matter experts. Below you can read more about one of these initiatives:

Subcutaneous drug delivery: PBPK-QSP model for absorption and anti-drug antibody response

PBPK-QSP benefits

Allow for scenarios beyond those observed


The independent representations of drug, biological entities and system parameters in PBPK-QSP models allow for extrapolation to scenarios beyond those observed. We see the main benefits with applying PBPK-QSP analyses as the following:

  • Distinctively addresses how a drug is absorbed, distributed, and eliminated, which allows for better understanding of each process and their respective association to drugs exposure and dynamics.
  • Via biopharmaceutics and administration route specific absorption models provide basis for optimized drug delivery, drug formulation and dosing strategies to improve drug performance and decisions in bridging. 
  • PBPK facilitates predictions of drug concentration at the site of pharmacological action. Combined with QSP modeling this provides a holistic and mechanistic understanding of the concentration/response relationship(s) of drugs in patients.
  • Enhances drug development programs including target validation, informing biomarker strategies, providing early-stage prediction of late-stage clinical outcome on a population level and/or identifying specific patient populations predicted to benefit from the drug candidate.
  • Common translational applications for PBPK-QSP modeling are First-In-Human trials support, biopharmaceutics and virtual bioequivalence (VBE) assessments, DDIs, special populations, like pediatrics, BMK identification, or early prediction of clinical efficacy.

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