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Background/Purpose <p>Aging alters how the body processes medications. Elderly patients often take multiple medications (polypharmacy) and are frequently excluded from clinical trials, making it difficult to determine safe and effective drug dosages. Physiologically Based Pharmacokinetic (PBPK) modeling offers a potential solution to this challenge. It integrates data from various sources to predict Absorption, Distribution, Metabolism, and Excretion (ADME) processes, and how age-related impairments impact these.</p> Recent Findings <p>There are several models which are built for geriatric population which have predicted drug behavior (ADME) in these population. Furthermore recent advances was also able to predict effect of hepatic and renal impairment on drugs which are common for this population. Recently, regulatory agencies like the FDA are also increasingly recommending PBPK modeling for applications such as metabolic drug-drug interaction assessment and supporting dosing recommendations. This review highlights the potential of PBPK modeling in predicting drug disposition in older people along with impairments by using case studies and published models.</p> Conclusion/Summary <p>PBPK modeling holds promise for improving drug therapy in the elderly by providing a deeper understanding of how aging impacts drug disposition. Advances are being made to optimize parameters which are not known and by increasing accuracy and prediction capabilities. By leveraging a deeper understanding of how aging impacts protein, enzyme, and transporter expression levels, PBPK modeling has the potential to guide dosing decisions in geriatric patients to ensure safe and effective drug therapy.</p> Future Advances <p>While PBPK modeling shows great potential, continued development and data sharing are needed to refine its accuracy. This includes improved characterization of age-related decline in organ function and expanding PBPK applications to evaluate the disposition of biological medicines in the elderly. Developments in regulations can also help to boost the research for this underrecognized population.</p>

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PBPK Modeling for Enhanced Drug Therapy in the Elderly Population and the Impact of Organ Impairment on Systemic Exposure

  • 期刊论文

  • 发表日期：

    2025年1月24日

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  • Kunj Vyas,
  • David R. Taft

摘要

Background/Purpose

Aging alters how the body processes medications. Elderly patients often take multiple medications (polypharmacy) and are frequently excluded from clinical trials, making it difficult to determine safe and effective drug dosages. Physiologically Based Pharmacokinetic (PBPK) modeling offers a potential solution to this challenge. It integrates data from various sources to predict Absorption, Distribution, Metabolism, and Excretion (ADME) processes, and how age-related impairments impact these.

Recent Findings

There are several models which are built for geriatric population which have predicted drug behavior (ADME) in these population. Furthermore recent advances was also able to predict effect of hepatic and renal impairment on drugs which are common for this population. Recently, regulatory agencies like the FDA are also increasingly recommending PBPK modeling for applications such as metabolic drug-drug interaction assessment and supporting dosing recommendations. This review highlights the potential of PBPK modeling in predicting drug disposition in older people along with impairments by using case studies and published models.

Conclusion/Summary

PBPK modeling holds promise for improving drug therapy in the elderly by providing a deeper understanding of how aging impacts drug disposition. Advances are being made to optimize parameters which are not known and by increasing accuracy and prediction capabilities. By leveraging a deeper understanding of how aging impacts protein, enzyme, and transporter expression levels, PBPK modeling has the potential to guide dosing decisions in geriatric patients to ensure safe and effective drug therapy.

Future Advances

While PBPK modeling shows great potential, continued development and data sharing are needed to refine its accuracy. This includes improved characterization of age-related decline in organ function and expanding PBPK applications to evaluate the disposition of biological medicines in the elderly. Developments in regulations can also help to boost the research for this underrecognized population.