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Models and Methods to Evaluate Transport of Drug Delivery Systems Across Cellular Barriers
18:57

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Published on: October 17, 2013

Application of method suitability for drug permeability classification.

Donna A Volpe1

  • 1Center for Drug Evaluation and Research, Silver Spring, Maryland 20993-0002, USA. donna.volpe@fda.hhs.gov

The AAPS Journal
|September 3, 2010
PubMed
Summary

Standardizing experimental permeability models is crucial for accurate drug absorption predictions. Method suitability ensures reliable data for drug discovery and development by validating assays and using reference compounds.

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Area of Science:

  • Pharmacokinetics
  • Drug Discovery and Development
  • Biopharmaceutical Sciences

Background:

  • Permeability models are vital for predicting oral drug absorption, but variability exists across different experimental systems.
  • Inconsistent results among laboratories necessitate assay standardization for reliable drug development applications.

Purpose of the Study:

  • To introduce and elaborate on the concept of method suitability for standardizing and validating experimental permeability models.
  • To highlight the importance of assay standardization for ensuring the dependability of experimental data in predicting drug intestinal permeability.

Main Methods:

  • Method suitability involves optimizing and validating assay methodology with defined acceptance criteria.
  • Demonstrating model suitability through rank-order correlations between experimental permeability and human absorption of known compounds.
  • Employing standard compounds to classify drug permeability and ensure assay reproducibility and quality.

Main Results:

  • Method suitability provides a generalized approach to standardize diverse permeability models (in situ, ex vivo, in vitro).
  • Standardization through reference standards and acceptance criteria enhances the dependability of experimental permeability data.
  • This approach assures the quality and reproducibility of permeability measurements for drug discovery and regulatory use.

Conclusions:

  • Method suitability is essential for validating experimental permeability models used in drug discovery and development.
  • Standardized assays and reference compounds are critical for reliable prediction of in vivo intestinal drug absorption.
  • Implementing method suitability ensures the consistent and dependable assessment of drug permeability across different laboratories and experimental setups.