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Development of nanomedicines and nano-similars: Recent advances in regulatory landscape.
Curr. Pharm. Des. 28, 165-177 (2021)
BACKGROUND: Nanopharmaceuticals serve as emerging forms of modern medicines which include nanomedicines, nanosimilars, nanotheranostics, nanodevices and many more. In last two decades, a large number of nano-based products has reached to the market and are being used clinically. OBJECTIVES: Unlike, conventional pharmaceutical products, nanopharmaceuticals behave differently both in vitro and in vivo and therefore, development of their generic versions needs special attention to replicate the similar drug release pattern leading to the identical therapeutic outcome. Further, drug-device combinations and 3D products are latest advancements in precise medicine delivery and development. METHODS: The regulatory guidelines for these products are being framed at many stages by various regulatory agencies like USFDA/EMA and still are in infancy at the moment if we look at wider prospective and applications of nanomedicine. RESULTS: For a formulation scientist, it is much needed that well-explained and directive guidelines should be available before leading to the development of the generic versions of these nano-cargos. CONCLUSION: Here, in this review, we have summarized the silent features of the regulatory perspectives related to the nanotechnology based next generation therapeutics and diagnostics.
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Publication type
Article: Journal article
Document type
Scientific Article
Keywords
Drug Delivery ; Nanodevices ; Nanomedicine ; Nanosimilars ; Nanotheranostics ; Pharmaceuticals ; Regulatory
ISSN (print) / ISBN
1381-6128
e-ISSN
1873-4286
Journal
Current Pharmaceutical Design
Quellenangaben
Volume: 28,
Issue: 2,
Pages: 165-177
Publisher
Bentham Science Publishers
Non-patent literature
Publications
Reviewing status
Peer reviewed
Institute(s)
Lung Health and Immunity (LHI)