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

Author(s):

Rishi Paliwal*, Pramod Kumar, Akash Chaurasiya, Rameshroo Kenwat, Sumeet Katke and Shivani Rai Paliwal  

Abstract:


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.

Keywords:

nanomedicine, nanosimilars, nanotheranostics, regulatory, pharmaceuticals, nanodevices, drug delivery

Affiliation:

Nanomedicine and Bioengineering Research Laboratory, Department of Pharmacy, Indira Gandhi National Tribal University, Amarkantak, MP, Helmholtz Zentrum München, Ingolstädter Landstraße 1 · D-85764 Neuherberg, Germany and Comprehensive Pneumology Center, Member of the German Center for Lung Research, Max-Lebsche-Platz 31, 81377 Munich, Department of Pharmacy, Birla Institute of Technology and Science, Pilani, Hyderabad, Nanomedicine and Bioengineering Research Laboratory, Department of Pharmacy, Indira Gandhi National Tribal University, Amarkantak, MP, Department of Pharmacy, Birla Institute of Technology and Science, Pilani, Hyderabad, SLT Institute of Pharmaceutical Sciences, Guru Ghasidas Vishwavidyalaya (A Central University), Bilaspur



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