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A Comprehensive Map of FDA-Approved Pharmaceutical Products
Hao Zhong; Ging Chan; Yuanjia Hu; Hao Hu; Defang Ouyang
2018-12-06
Source PublicationPHARMACEUTICS
ISSN1999-4923
Volume10Issue:4
Abstract

With the increasing research and development (R&D) difficulty of new molecular entities (NMEs), novel drug delivery systems (DDSs) are attracting widespread attention. This review investigated the current distribution of Food and Drug Administration (FDA)-approved pharmaceutical products and evaluated the technical barrier for the entry of generic drugs and highlighted the success and failure of advanced drug delivery systems. According to the ratio of generic to new drugs and the four-quadrant classification scheme for evaluating the commercialization potential of DDSs, the results showed that the traditional dosage forms (e.g., conventional tablets, capsules and injections) with a lower technology barrier were easier to reproduce, while advanced drug delivery systems (e.g., inhalations and nanomedicines) with highly technical barriers had less competition and greater market potential. Our study provides a comprehensive insight into FDA-approved products and deep analysis of the technical barriers for advanced drug delivery systems. In the future, the R&D of new molecular entities may combine advanced delivery technologies to make drug candidates into more therapeutically effective formulations.

KeywordDrug Delivery System Fda-approval Drugs Generic Drugs Oral Sustained-release Preparation Inhalation Complex Injection Transdermal Patch
DOI10.3390/pharmaceutics10040263
Indexed BySCI
Language英语
WOS Research AreaPharmacology & Pharmacy
WOS SubjectPharmacology & Pharmacy
CSCD IDWOS:000455853800101
PublisherMDPI, ST ALBAN-ANLAGE 66, CH-4052 BASEL, SWITZERLAND
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Cited Times [WOS]:10   [WOS Record]     [Related Records in WOS]
Document TypeJournal article
CollectionInstitute of Chinese Medical Sciences
Corresponding AuthorGing Chan; Defang Ouyang
AffiliationState Key Laboratory of Quality Research in Chinese Medicine, Institute of Chinese Medical Sciences (ICMS), University of Macau, Macau 999078, China
First Author AffilicationInstitute of Chinese Medical Sciences
Corresponding Author AffilicationInstitute of Chinese Medical Sciences
Recommended Citation
GB/T 7714
Hao Zhong,Ging Chan,Yuanjia Hu,et al. A Comprehensive Map of FDA-Approved Pharmaceutical Products[J]. PHARMACEUTICS,2018,10(4).
APA Hao Zhong,Ging Chan,Yuanjia Hu,Hao Hu,&Defang Ouyang.(2018).A Comprehensive Map of FDA-Approved Pharmaceutical Products.PHARMACEUTICS,10(4).
MLA Hao Zhong,et al."A Comprehensive Map of FDA-Approved Pharmaceutical Products".PHARMACEUTICS 10.4(2018).
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