Regulation, Development, and Commercialization of Nano-Based Drugs

Pp: 174-190 (17)

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Abstract

Nanopharmaceuticals necessitate rigorous, costly testing to address safety concerns, including cytotoxic effects. The lack of toxicity testing protocols and understanding of the interactions of nanomaterials make it difficult to make accurate assessments of health risks. To meet the purpose of regulating and monitoring nano products in pharmaceuticals, various nations have devised their suitable regulatory processes. Approximately two decades are required for drug development, which includes drug discovery, clinical testing, and production approval. However, only when a novel pharmaceutical product can be mass manufactured in industrially substantial quantities is its development considered to be accomplished. At present, nanodrugs have already been introduced successfully to the market, demonstrating their future potential. This chapter will provide comprehensive details about the drug development process covering regulations, development, and commercialization of nano-based drugs

Keywords: Crystalline NPs, Drug development, Drug commercialization, European medicines agency, FDA, Inorganic NPs, lipid-based NPs, Nano-drug regulation, Polymeric NPs.