Irritable bowel disease is typically situated towards the end of the human gastrointestinal tract thus, challenging and
restricting the efficacy of traditional drugs. Nanotechnology, regarded as a game-changer in the modern
pharmaceutical world has shown the advancement of drug performance in extraordinary ways up to laboratory scale.
Failure of standardized protocols, potential toxicity, inability to up-scale practice, among others have been mooted to
prevent the advancement of novel drug development using nanotechnology to commercialization. This study was
Qualitative. Data was collected using an Integrative Review of 144 articles. Specific quality control was adopted to
ensure that Validity (saturation) and Reliability (trustworthiness and repeatability) was established. This paper
culminated in a series of schematic frameworks of fundamental key strategies to advance the development of nano-
enabled drugs, responsibly, demonstrating mitigation strategies for hazard characterization, risk evaluation, risk
reduction and quality control along the lifecycle of product development for nano-enabled drugs.

Keywords
Nanotechnology, Innovation Drug Development, Risk Management and Quality Management

Krishnan Kanny

Affiliation

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Harmonizing Design, Risk, Metrology and Standardization in Managing the Development of Drugs using Nanotechnology.