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Applications of pharmacogenomics in regulatory science: a product life cycle review


With rapid developments of pharmacogenomics (PGx) and regulatory science, it is important to understand the current PGx integration in product life cycle, impact on clinical practice thus far and opportunities ahead. We conducted a cross-sectional review on PGx-related regulatory documents and implementation guidelines in the United States and Europe. Our review found that although PGx-related guidance in both markets span across the entire product life cycle, the scope of implementation guidelines varies across two continents. Approximately one-third of Food and Drug Administration (FDA)-approved drugs with PGx information in drug labels and half of the European labels posted on PharmGKB website contain recommendations on genetic testing. The drugs affected 19 and 15 World Health Organization Anatomical Therapeutic Chemical drug classes (fourth level) in the United States and Europe, respectively, with protein kinase inhibitors (13 drugs in the United States and 16 drugs in Europe) being most prevalent. Topics of emerging interest were novel technologies, adaptive design in clinical trial and sample collection.

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YYT acknowledges support from the Saw Swee Hock School of Public Health, National University of Singapore. YYT additionally acknowledges support by the National Research Foundation, Prime Minister’s Office, Singapore, under its Research Fellowship (NRF-RF-2010-05) and administered by the National University of Singapore.

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Correspondence to Y Y Teo.

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The views expressed in this article are the personal views of the authors and may not be understood or quoted as being made on behalf of or reflecting the position of the respective regulatory agencies or any of the committees or working parties.

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Tan-Koi, W., Leow, P. & Teo, Y. Applications of pharmacogenomics in regulatory science: a product life cycle review. Pharmacogenomics J 18, 359–366 (2018).

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