On the regulatory approval pathway of biosimilar products
10.3390/ph5040353
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2020
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sg-nus-scholar.10635-1808412024-11-08T22:59:40Z On the regulatory approval pathway of biosimilar products Wang, J Chow, S.-C DUKE-NUS MEDICAL SCHOOL biological product bioequivalence biological activity Canada clinical evaluation drug approval drug efficacy drug manufacture drug purity drug quality drug research drug safety drug stability European Medicines Agency European Union food and drug administration government regulation Japan Korea medical society organization pharmacodynamics pharmacokinetics physical chemistry political participation practice guideline review United States world health organization 10.3390/ph5040353 Pharmaceuticals 5 4 353-368 2020-10-27T04:55:45Z 2020-10-27T04:55:45Z 2012 Review Wang, J, Chow, S.-C (2012). On the regulatory approval pathway of biosimilar products. Pharmaceuticals 5 (4) : 353-368. ScholarBank@NUS Repository. https://doi.org/10.3390/ph5040353 1424-8247 https://scholarbank.nus.edu.sg/handle/10635/180841 Attribution 4.0 International http://creativecommons.org/licenses/by/4.0/ Unpaywall 20201031 |
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biological product bioequivalence biological activity Canada clinical evaluation drug approval drug efficacy drug manufacture drug purity drug quality drug research drug safety drug stability European Medicines Agency European Union food and drug administration government regulation Japan Korea medical society organization pharmacodynamics pharmacokinetics physical chemistry political participation practice guideline review United States world health organization |
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biological product bioequivalence biological activity Canada clinical evaluation drug approval drug efficacy drug manufacture drug purity drug quality drug research drug safety drug stability European Medicines Agency European Union food and drug administration government regulation Japan Korea medical society organization pharmacodynamics pharmacokinetics physical chemistry political participation practice guideline review United States world health organization Wang, J Chow, S.-C On the regulatory approval pathway of biosimilar products |
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10.3390/ph5040353 |
author2 |
DUKE-NUS MEDICAL SCHOOL |
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DUKE-NUS MEDICAL SCHOOL Wang, J Chow, S.-C |
format |
Review |
author |
Wang, J Chow, S.-C |
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Wang, J |
title |
On the regulatory approval pathway of biosimilar products |
title_short |
On the regulatory approval pathway of biosimilar products |
title_full |
On the regulatory approval pathway of biosimilar products |
title_fullStr |
On the regulatory approval pathway of biosimilar products |
title_full_unstemmed |
On the regulatory approval pathway of biosimilar products |
title_sort |
on the regulatory approval pathway of biosimilar products |
publishDate |
2020 |
url |
https://scholarbank.nus.edu.sg/handle/10635/180841 |
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1821214942014996480 |