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Published on:February 2019
Indian Journal of Pharmaceutical Education and Research, 2019; 53(2):192-201
Review Article | doi:10.5530/ijper.53.2.25

Ethical and Administrative Implications of Nanoscale Technology for Efficient and Safe Delivery of Drugs: Analytical and Regulatory Aspects


Authors and affiliation (s):

Gaurav Tiwari*, Ruchi Tiwari, Pranay Wal

Department of Pharmaceutics, Pranveer Singh Institute of Technology, Kalpi Road, Bhauti, Kanpur-208020, Uttar Pradesh, INDIA.

Abstract:

Background: Cutting-edge issues for nanomedicine involve knowledge of the problems associated with toxicity and environmental effect of nanoscale substances (substances whose structure is on the dimensions of nanometers, i.e. billionths of a meter). Nanoparticles are able to reach inner biomolecules, which is not possible for larger debris. Materials and Methods: The nanosuspension turned into analytically characterized and subjected to regulatory aspects. Scientific facts used to make regulatory decisions about merchandise starting from cosmetics to chemotherapy agents to food packaging, FDA has lengthy encountered the combination of promise, threat and uncertainty that accompanies emerging technologies. Nanotechnology is not specific on this regard. Present article covered about regulatory aspects of Abbreviated New Drug Application (ANDA) and Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH). Conclusion: The objective of this review is to know about the FDA regulations towards nanotechnology and various techniques used to analyze this tiny technology for drug delivery.

Key words: Nanosize particles, FDA regulations, Industrial application, Analytical studies and Nanomaterial safety.

 

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The Official Journal of Association of Pharmaceutical Teachers of India (APTI)
(Registered under Registration of Societies Act XXI of 1860 No. 122 of 1966-1967, Lucknow)

Indian Journal of Pharmaceutical Education and Research (IJPER) [ISSN-0019-5464] is the official journal of Association of Pharmaceutical Teachers of India (APTI) and is being published since 1967.

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