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Clearance constants in physiologically based pharmacokinetic models.

H S Chen, J F Gross

    Journal of Pharmaceutical Sciences
    |August 1, 1979
    PubMed
    Summary
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    Physiologically based pharmacokinetic models often approximate intrinsic clearance using apparent clearance. This study reveals this approximation is unreliable for high extraction ratio drugs, leading to significant errors in clearance and extraction ratio estimations.

    Area of Science:

    • Pharmacokinetics
    • Drug Metabolism
    • Quantitative Systems Pharmacology

    Background:

    • Physiologically based pharmacokinetic (PBPK) models are crucial for drug development.
    • Intrinsic clearance is a key parameter in PBPK models.
    • PBPK models commonly approximate intrinsic clearance using apparent clearance.

    Purpose of the Study:

    • To derive and analyze the exact relationship between intrinsic clearance and apparent clearance.
    • To evaluate the accuracy of approximating intrinsic clearance with apparent clearance under varying drug extraction ratios.

    Main Methods:

    • Mathematical derivation of the relationship between intrinsic and apparent clearance.
    • Analysis of the approximation's accuracy based on drug extraction ratio.

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    Main Results:

    • The approximation of intrinsic clearance by apparent clearance is accurate for drugs with low extraction ratios (ER < 0.05).
    • Significant errors occur when using this approximation for high extraction ratio drugs (ER > 0.2).
    • Errors can lead to a 50% underestimation of the extraction ratio and an order-of-magnitude difference in intrinsic clearance.

    Conclusions:

    • The approximation of intrinsic clearance by apparent clearance is not universally applicable in PBPK modeling.
    • Careful consideration of the drug's extraction ratio is necessary when applying this approximation.
    • The findings highlight potential inaccuracies in PBPK models for high extraction ratio drugs.