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Related Concept Videos

Clinical Trials: Overview01:11

Clinical Trials: Overview

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Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
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Preclinical Development: Overview01:28

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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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Clinical Trials01:16

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Clinical trials are prospective experimental studies conducted on humans to determine the safety and efficacy of treatments, drugs, diet methods, and medical devices. Using statistics in clinical trials enables researchers to derive reasonable and accurate conclusions from the collected data, allowing them to make wise decisions in uncertain situations. In medical research, statistical methods are crucial for preventing errors and bias.
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Updated: Jun 14, 2025

Evaluating Regional Pulmonary Deposition using Patient-Specific 3D Printed Lung Models
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Phase 0 trials/ Intra-Target-Microdosing (ITM) and the lung: a review.

Tom M Quinn1,2, Annya M Bruce3, Tal Burt4

  • 1Baillie Gifford Pandemic Science Hub, Centre for Inflammation Research, Institute for Regeneration & Repair, Edinburgh BioQuarter, University of Edinburgh, Edinburgh, UK. tquinn@ed.ac.uk.

BMC Pulmonary Medicine
|August 29, 2024
PubMed
Summary
This summary is machine-generated.

Phase 0 trials accelerate drug discovery using microdoses. Intra-Target Microdosing (ITM) enhances early pharmacokinetic (PK) and pharmacodynamic (PD) data collection for respiratory disease treatments, improving efficiency and reducing animal testing.

Keywords:
Drug developmentExperimental medicinePhase 0/ microdosingRespiratory Medicine

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Area of Science:

  • Pharmacology
  • Clinical Pharmacology
  • Drug Discovery

Background:

  • The COVID-19 pandemic underscored the need for efficient respiratory disease drug discovery.
  • Traditional clinical trials are costly and inefficient, leading to high drug attrition rates.
  • Early-stage drug development faces challenges with predicting efficacy and safety.

Purpose of the Study:

  • To introduce and evaluate the Intra-Target Microdosing (ITM) approach for early drug development.
  • To enhance the collection of pharmacokinetic (PK) and pharmacodynamic (PD) data in Phase 0 trials.
  • To improve the efficiency and cost-effectiveness of developing new and repurposed respiratory drugs.

Main Methods:

  • Phase 0 trials utilize sub-clinical microdoses for early human testing.
  • Traditional methods focus on systemic PK data using techniques like AMS, LC-MS/MS, and PET.
  • The ITM approach exposes a small body compartment to local concentrations for PD and target engagement data.

Main Results:

  • ITM allows for direct collection of local PD data and target engagement evidence.
  • ITM facilitates extrapolation of both systemic PK and PD data.
  • This method offers a more robust assessment compared to traditional PK-focused extrapolation.

Conclusions:

  • ITM represents a significant advancement for Phase 0 trials, particularly in respiratory medicine.
  • The approach promises more efficient and cost-effective drug development, reducing reliance on animal models.
  • ITM has the potential to accelerate the study and development of novel and repurposed pulmonary drugs.