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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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Mice have long served as models for studying human biology and pathology because of their phylogenetic and physiological similarity with humans. They are also easy to maintain and breed in the laboratory, and hence, many inbred strains are now available for research. Studies on mice have contributed immeasurably to our understanding of cancer biology.
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Ethics in Research01:56

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Today, scientists agree that good research is ethical in nature and is guided by a basic respect for human dignity and safety. However, this has not always been the case. Modern researchers must demonstrate that the research they perform is ethically sound.
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Redefining preclinical testing: human-relevant alternatives beyond animal models.

Jieun Jang, Wonjun Yang, Hanseul Yang

  • 1Biotherapeutics Translational Research Center, Korea Research Institute of Bioscience and Biotechnology, Daejeon 34141; Department of Biomolecular Science, Korea Research Institute of Bioscience and Biotechnology, School of Bioscience, Korea University of Science and Technology, Daejeon 34141, Korea.

BMB Reports
|September 17, 2025
PubMed
Summary

Ethical and scientific concerns are driving a move away from animal testing in drug development. New human-relevant in vitro and in silico models offer advanced alternatives for toxicity testing and precision medicine.

Area of Science:

  • Biomedical Science
  • Toxicology
  • Drug Development

Background:

  • Traditional animal models face ethical and scientific limitations for toxicity testing and drug evaluation.
  • Precision medicine necessitates human-relevant and mechanistically informed preclinical testing methods.

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