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Related Concept Videos

Drug Discovery: Overview01:26

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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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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 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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Related Experiment Video

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Reimagining human-centric drug development with new approach methodologies.

Xuekun Wu1,2, Matthew A Wu1, James Zou3,4

  • 1Stanford Cardiovascular Institute, Stanford University School of Medicine, Stanford, CA, USA.

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New approach methodologies (NAMs) bridge the gap between preclinical models and human biology, improving drug development. These human-centric methods, supported by regulatory changes, offer a more predictive and ethical path forward.

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Area of Science:

  • Biomedical research
  • Drug development
  • Toxicology

Background:

  • Most drug candidates fail in clinical trials due to limitations in preclinical models.
  • A significant gap persists between animal models and human biology.
  • Technological advancements necessitate new methods in drug evaluation.

Purpose of the Study:

  • To review emerging biological and computational New Approach Methodologies (NAMs).
  • To examine the integration of NAMs in reshaping drug development.
  • To discuss regulatory and ethical frameworks for NAM implementation.

Main Methods:

  • Synthesis of current biological and computational NAMs.
  • Analysis of regulatory reforms, including the FDA Modernization Act 3.0.
  • Examination of ethical considerations for human-centered drug development.

Main Results:

  • NAMs, including human-derived cells and AI, offer a paradigm shift.
  • NAMs are positioned to complement or replace animal testing.
  • Integration of NAMs promises more predictive and efficient drug development.

Conclusions:

  • NAMs represent a crucial transition towards human-centric drug development.
  • Regulatory and ethical frameworks are essential for successful NAM adoption.
  • A roadmap is proposed for embedding NAMs into a predictive and ethical infrastructure.