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14 - Quality Assurance and Regulatory Issues of Nanomedicine for the Pharmaceutical Industry

Published online by Cambridge University Press:  08 March 2022

James F. Leary
James F. Leary
Affiliation:
Purdue University, Indiana
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Summary

This chapter describes quality assurance and regulatory issues and how different government agencies approach the problem of determining whether new nanomedical systems are safe and effective. Nanomedical systems are both a device and a drug. Testing in humans after animals occurs in precise regulatory stages of clinincal trials. Regulatory agencies also assess potential damage to the environment and monitor worker safety issues.

Keywords

quality assurance issues for reproducibilityhow to testregulatory issuesgood manufacturing practices (GMP)enforcing regulationsroles of different regulatory agenciesFDA approval processclinical trial stagesenvironmental factorsworker safety issues
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Chapter
Information
Fundamentals of Nanomedicine , pp. 279 - 309
Publisher: Cambridge University Press
Print publication year: 2022

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