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Related Concept Videos

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Preclinical development consists of a series of tests that ensure the safety and efficacy of a new therapeutic compound before it is tested in humans. There are four main phases to this process. First, safety pharmacology tests are conducted to ensure the drug does not produce any acutely harmful effects. These tests examine parameters such as bronchoconstriction, cardiac dysrhythmias, blood pressure changes, and ataxia. Next, preliminary toxicological testing is performed to determine the...
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Drug discovery is a multifaceted process involving extensive screening, testing, and optimization of lead compounds to identify potential new drugs for therapeutic use. It combines several approaches, including screening large numbers of natural products, chemical modification of known active molecules, identification of new drug targets, and rational design based on biological mechanisms and drug-receptor structure. These approaches are carried out in both academic research laboratories and...
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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.
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When it comes to infants and young children, they are typically administered smaller doses of medication in comparison to adults. This is primarily because their organ functions still need to fully develop, meaning their bodies are not as efficient at metabolizing or eliminating drugs. Additionally, their blood-brain barrier is more permeable than in adults. As a result, high concentrations of drugs can easily penetrate the central nervous system (CNS), potentially leading to neurological...
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Physiological pharmacokinetic models, often called flow-limited or perfusion models, typically assume a swift drug distribution between tissue and venous blood, creating a rapid drug equilibrium. This premise is based on the idea that drug diffusion is extremely fast, and the cell membrane presents no barrier to drug permeation. In this scenario, where no drug binding occurs, the drug concentration in the tissue equals that of the venous blood leaving the tissue. This greatly simplifies the...
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Related Experiment Video

Updated: Jun 4, 2025

An Intestine/Liver Microphysiological System for Drug Pharmacokinetic and Toxicological Assessment
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Opportunities and challenges for human microphysiological systems in drug development.

Shekh M Rahman1, Ashok Krishna1, Catherine Sullenberger1

  • 1Division of Applied Regulatory Science (DARS), Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, United States Food and Drug Administration (FDA), Silver Spring, MD, USA.

ALTEX
|January 2, 2025
PubMed
Summary

Microphysiological systems (MPS) offer advanced in vitro models for drug development, aiding disease modeling and safety assessments. Standardization and regulatory acceptance are key to maximizing their potential in nonclinical testing.

Keywords:
complex in vitro modelsdrug developmentmicrophysiological systemsregulatory applicationssafety assessment

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Area of Science:

  • Biomedical Engineering
  • Pharmacology
  • Toxicology

Background:

  • Microphysiological systems (MPS) are sophisticated in vitro models using human or animal cells from various tissues and organs.
  • Despite limitations like lack of standardization, MPS show promise in drug development.
  • Further research and regulatory acceptance are crucial for enhancing MPS effectiveness.

Purpose of the Study:

  • To review the applications of human liver, gut, lung, and cardiac MPS in drug development.
  • To focus on disease modeling, safety assessment, and pharmacokinetic studies.
  • To discuss technical parameters, endpoints, and challenges in MPS development and implementation.

Main Methods:

  • Review of current literature on microphysiological systems (MPS) in drug development.
  • Analysis of applications in disease modeling, safety, and pharmacokinetics.
  • Discussion of technical parameters, assessment endpoints, and challenges.

Main Results:

  • Human liver, gut, lung, and cardiac MPS show significant potential in drug development.
  • Key applications include disease modeling, safety evaluation, and pharmacokinetic studies.
  • Challenges such as standardization, cell sourcing, and reproducibility need addressing.

Conclusions:

  • Collaborative efforts are essential for developing standardized protocols and validation criteria for MPS.
  • Advancements in MPS are expected to improve the predictivity and reliability of nonclinical testing.
  • MPS are poised to transform drug development and regulatory processes.