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14 - Quality Assurance and Regulatory Issues of Nanomedicine for the Pharmaceutical Industry
James F. Leary, Purdue University, Indiana
Book:

Fundamentals of Nanomedicine

Published online:

08 March 2022

Print publication:

31 March 2022, pp 279-309
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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.

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

Summary