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Identification and application of biomarkers in life cycle of drugs
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Yuan-yuan XIE1, 3, 4, Yi-ming WANG2, Guo-an LUO*, 2
Acta Pharmaceutica Sinica | 2021, 56(2) : 456 - 464
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Acta Pharmaceutica Sinica | 2021, 56(2): 456-464
• Reviews •
Identification and application of biomarkers in life cycle of drugs
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Yuan-yuan XIE1, 3, 4, Yi-ming WANG2, Guo-an LUO*, 2
Affiliations
  • 1. School of Traditional Chinese Medicine, Guangdong Pharmaceutical University, Guangzhou 510006, China
  • 2. Department of Chemistry, Tsinghua University, Beijing 100084, China
  • 3. Key Laboratory of Digital Quality Evaluation of Chinese Material Medical of SATCM, Guangzhou 510006, China
  • 4. Engineering Technology Research Center for Chinese Materia Medical Quality of Guangdong Province, Guangzhou 510006, China
Published: 2021-02-12 doi: 10.16438/j.0513-4870.2020-1374
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Biomarkers are defined as a characteristic that is objectively measured and evaluated as an indicator of normal biological processes, pathogenic processes, or pharmacological responses to a therapeutic intervention.Biomarkers can help the decision-making process for new drug research and development, provide guidance for the early clinical development of candidate drugs and reduce the risk of failure. Therefore, as a key factor in the development of new drugs, the discovery and research on biomarkers has increased the interest of the pharmaceutical industry and regulatory agencies. Guidelines on the development and use of biomarkers have been issued by drug regulatory agencies including the EMA, FDA and ICH. Biomarkers are encouraged to be used to facilitate drug development by these relevant regulatory agencies, and also to be used to monitor the safety and efficacy of drugs in post-marketing drug surveillance. The application of biomarkers is encouraged at different stages of a drug's life cycle, including at the stage of basic science research and target identification, prototype design or discovery, preclinical development, clinical development, FDA filling/approval and launch, as well as post-marketing was reviewed. The identification, development, and application of biomarkers in pharmaceutical research is discussed.

biomarker  /  life cycle of drug  /  drug discovery  /  efficacy  /  safety
Yuan-yuan XIE, Yi-ming WANG, Guo-an LUO. Identification and application of biomarkers in life cycle of drugs[J]. Acta Pharmaceutica Sinica, 2021 , 56 (2) : 456 -464 . DOI: 10.16438/j.0513-4870.2020-1374
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Article Info
doi: 10.16438/j.0513-4870.2020-1374
  • Receive Date：2020-08-19
  • Online Date：2025-12-18
  • Published：2021-02-12
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History
  • Received：2020-08-19
  • Revised：2020-10-21
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Affiliations
    1. School of Traditional Chinese Medicine, Guangdong Pharmaceutical University, Guangzhou 510006, China
    2. Department of Chemistry, Tsinghua University, Beijing 100084, China
    3. Key Laboratory of Digital Quality Evaluation of Chinese Material Medical of SATCM, Guangzhou 510006, China
    4. Engineering Technology Research Center for Chinese Materia Medical Quality of Guangdong Province, Guangzhou 510006, China
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