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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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Drugs, the chemical agents used in diagnosing, treating, or preventing diseases, undergo a four-phase process of development: pharmaceutic, pharmacokinetics, pharmacodynamics, and therapeutic.
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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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Phase I biotransformation, or functionalization, is a crucial chemical process that converts drugs and other xenobiotics into more water-soluble forms, facilitating expulsion from the body. It involves oxidative, reductive, and hydrolytic reactions that add or unveil polar functional groups on lipophilic substrates. Key players in phase I reactions are the mixed-function oxidases. Situated in liver cell microsomes, these enzymes predominantly carry out drug metabolism. They require molecular...
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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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Updated: Dec 9, 2025

An Intestine/Liver Microphysiological System for Drug Pharmacokinetic and Toxicological Assessment
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Phase 0/microdosing approaches: time for mainstream application in drug development?

Tal Burt1,2, Graeme Young3, Wooin Lee4

  • 1Burt Consultancy LLC. talburtmd.com, New York, NY, USA. tburt@phase-0microdosing.org.

Nature Reviews. Drug Discovery
|September 9, 2020
PubMed
Summary
This summary is machine-generated.

Phase 0 studies, including microdosing, evaluate subtherapeutic drug exposures in early human trials. These exploratory clinical trials improve drug development by enhancing candidate selection and informing decisions, leading to safer and more efficient processes.

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Area of Science:

  • Pharmacology and Drug Development
  • Clinical Trial Design
  • Translational Medicine

Background:

  • Traditional drug development is lengthy and costly.
  • Early-stage drug evaluation often lacks comprehensive mechanistic insights.
  • Phase 0 exploratory studies offer a novel approach to early drug assessment.

Purpose of the Study:

  • To discuss the methods and applications of Phase 0 approaches.
  • To highlight the advantages of Phase 0 over traditional drug development strategies.
  • To address concerns regarding extrapolation and developmental timelines in Phase 0 studies.

Main Methods:

  • Utilizing subtherapeutic drug exposures in first-in-human studies (microdosing).
  • Evaluating pharmacokinetics, pharmacodynamics, and mechanism of action.
  • Conducting exploratory clinical trials to gather early human data.

Main Results:

  • Phase 0 studies provide insights beyond pharmacokinetics, including mechanism of action.
  • These approaches can significantly improve preclinical candidate selection.
  • Phase 0 enables safer, more cost-effective, and informed drug development decisions.

Conclusions:

  • Phase 0 approaches offer substantial benefits for drug development.
  • Despite remaining challenges, Phase 0 should be considered for most drug development programs.
  • Wider adoption of Phase 0 can lead to more efficient and successful drug discovery.