On the regulatory approval pathway of biosimilar products

10.3390/ph5040353

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Bibliographic Details
Main Authors: Wang, J, Chow, S.-C
Other Authors: DUKE-NUS MEDICAL SCHOOL
Format: Review
Published: 2020
Subjects:
Online Access:https://scholarbank.nus.edu.sg/handle/10635/180841
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Institution: National University of Singapore
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spelling 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
institution National University of Singapore
building NUS Library
continent Asia
country Singapore
Singapore
content_provider NUS Library
collection ScholarBank@NUS
topic 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
spellingShingle 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
description 10.3390/ph5040353
author2 DUKE-NUS MEDICAL SCHOOL
author_facet DUKE-NUS MEDICAL SCHOOL
Wang, J
Chow, S.-C
format Review
author Wang, J
Chow, S.-C
author_sort 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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