Pharmacokinetic Simulation Modeling
Intellipharm has refocused its mission to providing open source code for building physiologically based pharmacokinetic models and related training. As always,
Intellipharm provides pharmaceutical consulting services for oral drug formulation development and discovery support.
will soon publish Computer Simulation For Pharmaceutical Scientists
by Kevin C. Johnson. This new book teaches how to write code to develop
physiologically based pharmacokinetic simulations that will provide insights to guide the drug formulation development before committing large expenditures
for laboratory and clinical studies.
Pharmaceutical simulations can streamline the drug development process by mimicking essential biopharmaceutical
processes including drug dissolution, absorption, and disposition. Here are some of the things you can do with Intellipharm code:
- Set drug particle size specifications to avoid variability with regard to dissolution, absorption, and content uniformity.
- Select drugs for development based on a comprehensive analysis of all pertinent data: dose, metabolism, solubility, permeability, etc.
- Develop a discriminating dissolution test.
- Determine when experimental samples should be taken.
- Institute a quality by design strategy by adopting mechanistically based pharmaceutical simulations.
- Determine drug release rate for a controlled-release formulation.
- Determine drug particle size from dissolution data.
- Deconvolute permeability or absorption rate constant from pharmacokinetic data that is confounded by dissolution-rate-limited absorption.
- Identify problems with poor formulation disintegration and wetting by comparing actual and simulated dissolution rates.
- Identify drugs that will need more than particle size reduction to improve absorption.
- Determine if poor absorption or first-pass metabolism is the cause of low bioavailability.
- Compute the volume of fluid available in the gastrointestinal tract by matching it to the value that explains plateauing drug plasma levels
in a dose escalation study.
- Model drug precipitation in a mechanistic way to study its effect on drug absorption.