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Related Concept Videos

Physiological Pharmacokinetic Models: Incorporating Hepatic Transporter-Mediated Clearance01:07

Physiological Pharmacokinetic Models: Incorporating Hepatic Transporter-Mediated Clearance

Drug transporters are critical in drug absorption, distribution, and excretion processes. They should be included in physiological-based pharmacokinetic (PBPK) models, which help predict human drug disposition. However, predicting this is challenging during drug development, especially when liver transport is involved. However, with a realistic representation of body transport processes, an accurate model may be possible.
A recent model describes pravastatin's hepatobiliary excretion, mediated...
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Pharmacokinetic-pharmacodynamic (PK–PD) modeling is essential in drug development and clinical pharmacology. It provides a quantitative framework to predict drug behavior and response over time. This approach integrates pharmacokinetics (PK), which describes the drug's absorption, distribution, metabolism, and excretion, with pharmacodynamics (PD), which characterizes the drug’s biological effects and mechanisms of action.The disposition kinetics of a drug determine its plasma...
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Pharmacokinetic–Pharmacodynamic Relationship: Problems

The empirical approach to drug therapy optimization relies on correlating pharmacological response with administered dosage. Such an approach can be costly, time-consuming, and often yields poor correlation due to variables like formulation factors and drug elimination characteristics. A more precise approach correlates response with plasma drug concentration or the amount of drug in the body, rather than dosage. This is achieved through pharmacokinetic-pharmacodynamic (PK/PD) modeling, which...
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It is not uncommon for complete drug pharmacokinetic profiles to remain elusive in pharmacokinetics. This necessitates certain educated assumptions by pharmacokineticists to determine appropriate dosage regimens without comprehensive pharmacokinetic data from animal or human studies. One prevalent assumption is setting the bioavailability factor, denoted as F, to 1 or 100%. This assumption caters to the scenario where a drug doesn't achieve full systemic absorption, resulting in the patient...
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Physiological models with protein binding in pharmacokinetics offer a sophisticated approach to understanding drug disposition. These models consider drug-protein interactions, enabling them to effectively predict drug concentrations in different organs and tissues. This precision aids in accurate drug dosing, providing a significant advantage over conventional models. A key process within these models is equilibration, which ensures that drug concentrations achieve a steady state within the...
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Physiological models in pharmacokinetics are instrumental in understanding the distribution and elimination of drugs within the body. These models describe the drug concentration within target organs, influenced by factors such as drug uptake, tissue volume, and blood flow. Drug uptake is governed by the partition coefficient, which signifies the drug concentration ratio in tissue to that in the blood. The blood flow rate to a specific tissue is expressed as Qt, and the rate of change in tissue...

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An Intestine/Liver Microphysiological System for Drug Pharmacokinetic and Toxicological Assessment
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Published on: December 3, 2020

Physiologically based pharmacokinetics (PBPK).

Pascal Espié1, Dominique Tytgat, Maria-Laura Sargentini-Maier

  • 1UCB Pharma SA, Belgium.

Drug Metabolism Reviews
|July 16, 2009
PubMed
Summary

Physiologically based pharmacokinetic (PBPK) models offer improved cross-species prediction of drug behavior compared to simple allometry. PBPK models integrate diverse data for more accurate pharmacokinetic and pharmacodynamic extrapolation.

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Area of Science:

  • Pharmacokinetics and Drug Metabolism
  • Translational Pharmacology
  • Computational Biology

Background:

  • Allometric scaling is a common method for predicting human pharmacokinetics from preclinical species.
  • Simple allometry often yields prediction errors, particularly when hepatic clearance depends on non-allometric enzyme activities.
  • This highlights the need for more robust extrapolation methods.

Purpose of the Study:

  • To introduce Physiologically Based Pharmacokinetic (PBPK) models as an advanced approach for cross-species pharmacokinetic extrapolation.
  • To emphasize the advantages of PBPK models over traditional allometric scaling.

Main Methods:

  • PBPK models integrate drug-specific, physiological, and biological parameters.
  • These models account for variations across species, subjects, age, and disease states.
  • PBPK models provide a mechanistic basis for pharmacokinetic predictions.

Main Results:

  • PBPK models enable accurate extrapolation of drug behavior across different doses, routes, and species.
  • They offer richer information content compared to conventional pharmacokinetic models.
  • PBPK modeling facilitates mechanistic pharmacokinetic-pharmacodynamic (PK/PD) modeling.

Conclusions:

  • PBPK models represent a significant advancement in predicting human pharmacokinetics from preclinical data.
  • Their mechanistic and data-integrative nature overcomes limitations of simple allometry.
  • PBPK modeling provides a versatile framework for drug development and risk assessment.