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In Vitro Biopredictive Methods: A Workshop Summary Report.

Xavier J H Pepin1, Jennifer Dressman2, Neil Parrott3

  • 1New Modalities and Parenteral Development, Pharmaceutical Technology & Development, Operations, AstraZeneca, Macclesfield, UK.

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|September 21, 2020
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Summary
This summary is machine-generated.

This workshop explored challenges in measuring in vitro drug properties for physiologically based biopharmaceutics models (PBBM). Key discussions focused on optimizing solubility, dissolution, and permeability measurements for accurate drug development predictions.

Keywords:
BioequivalenceBiopredictive dissolutionCQAsIVIVCIVIVRModelingPBBMPBPKPermeabilityPrecipitationSolubility

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Area of Science:

  • Pharmacology
  • Drug Development
  • Biopharmaceutics

Background:

  • Physiologically based biopharmaceutics models (PBBM) link drug product quality to in vivo performance.
  • Reliable PBBM predictions depend on accurate in vitro input measurements.
  • Translational modeling is crucial for drug product development and manufacturing controls.

Purpose of the Study:

  • Summarize Day 1 proceedings of a workshop on translational modeling strategies.
  • Identify best practices and challenges in measuring in vitro inputs for PBBM.
  • Discuss strategies for solubility, dissolution, and permeability assessments.

Main Methods:

  • Workshop report summarizing podium presentations and breakout session discussions.
  • Focus on in vitro measurements relevant to physiologically based biopharmaceutics models.
  • Exploration of challenges in gastrointestinal system parameter description.

Main Results:

  • Best strategies for determining drug solubility, supersaturation, and critical supersaturation were discussed.
  • Development of biopredictive (clinically relevant) dissolution methods was examined.
  • Challenges in describing gastrointestinal parameters (mucus, volume, motility) and translating permeability measures were highlighted.

Conclusions:

  • Accurate in vitro measurements are essential for reliable physiologically based biopharmaceutics models.
  • Further research is needed to address challenges in gastrointestinal parameter modeling and permeability translation.
  • Optimizing these inputs will enhance drug product development and manufacturing controls.