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Related Concept Videos

Dosage Regimens: Partial Pharmacokinetic Parameters01:01

Dosage Regimens: Partial Pharmacokinetic Parameters

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...
Pharmacokinetic Models: Comparison and Selection Criterion01:26

Pharmacokinetic Models: Comparison and Selection Criterion

Physiological and compartmental models are valuable tools used in studying biological systems. These models rely on differential equations to maintain mass balance within the system, ensuring an accurate representation of the dynamic processes at play.
Physiological models take a detailed approach by considering specific molecular processes. They can predict drug distribution, metabolism, and elimination changes, providing a comprehensive understanding of how drugs interact with the body.
Pharmacokinetic–Pharmacodynamic Relationship: Problems01:24

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...
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...
Pharmacokinetic–Pharmacodynamic Relationship: Model Components01:14

Pharmacokinetic–Pharmacodynamic Relationship: Model Components

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...
Pharmacodynamic Models: Overview01:27

Pharmacodynamic Models: Overview

Pharmacodynamic (PD) responses describe the interaction between a drug and its biological target, culminating in a physiological effect. These responses can be classified into different types: continuous variables, such as blood glucose levels; categorical outcomes, like survival rates; and time-to-event metrics, such as disease progression. Understanding and modeling PD responses are critical for optimizing drug efficacy and safety.PD models describe the relationship between drug concentration...

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Use of Rabbit Eyes in Pharmacokinetic Studies of Intraocular Drugs
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Dose selection based on physiologically based pharmacokinetic (PBPK) approaches.

Hannah M Jones1, Kapil Mayawala, Patrick Poulin

  • 1Systems Modelling and Simulation Group, Department of Pharmacokinetics, Dynamics and Metabolism, Pfizer Worldwide R&D, 35 Cambridgepark Drive, Cambridge, MA 02140, USA. Hannah.Jones@pfizer.com

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Physiologically based pharmacokinetic (PBPK) models integrate preclinical data to predict human drug pharmacokinetics (PK) and dosing. These mechanistic models enhance efficiency and reduce animal testing in drug development.

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Area of Science:

  • Pharmacology
  • Biomedical Engineering
  • Computational Biology

Background:

  • Physiologically based pharmacokinetic (PBPK) models utilize differential equations to represent biological systems.
  • These models integrate in vitro and in vivo preclinical data to estimate pharmacokinetic (PK) parameters and concentration-time profiles.
  • PBPK models offer mechanistic insights into compound properties and facilitate extrapolation across diverse systems and populations.

Purpose of the Study:

  • To demonstrate the utility of PBPK modeling techniques for predicting human pharmacokinetics (PK) and dosage.
  • To showcase the application of PBPK modeling using small and large molecule examples.
  • To highlight the potential of PBPK approaches in advancing drug discovery and development.

Main Methods:

  • Construction of PBPK models using differential equations based on physiological and anatomical data.
  • Incorporation of readily available in vitro and in vivo preclinical data.
  • Application of PBPK techniques to predict human PK and dose for small and large molecules.

Main Results:

  • PBPK models successfully estimated PK parameters and plasma concentration-time profiles.
  • Demonstrated mechanistic understanding of compound properties through PBPK analysis.
  • Validated PBPK techniques for human PK and dose prediction using literature and company examples.

Conclusions:

  • PBPK modeling provides a powerful mechanistic framework for understanding and extrapolating PK and dose.
  • These models have the potential to increase efficiency, reduce animal studies, and enhance PK understanding in drug development.
  • Addressing current limitations will broaden the application and utility of PBPK modeling in drug discovery and development.