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Paliwal, R.* ; Kumar, P. ; Chaurasiya, A.* ; Kenwat, R.* ; Katke, S.* ; Paliwal, S.R.*

Development of nanomedicines and nano-similars: Recent advances in regulatory landscape.

Curr. Pharm. Des. 28, 165-177 (2021)
Postprint DOI PMC
Open Access Green
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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Publikationstyp Artikel: Journalartikel
Dokumenttyp Wissenschaftlicher Artikel
Korrespondenzautor
Schlagwörter Drug Delivery ; Nanodevices ; Nanomedicine ; Nanosimilars ; Nanotheranostics ; Pharmaceuticals ; Regulatory
ISSN (print) / ISBN 1381-6128
e-ISSN 1873-4286
Zeitschrift Current Pharmaceutical Design
Quellenangaben Band: 28, Heft: 2, Seiten: 165-177 Artikelnummer: , Supplement: ,
Verlag Bentham Science Publishers
Nichtpatentliteratur Publikationen
Begutachtungsstatus Peer reviewed
Institut(e) Lung Health and Immunity (LHI)