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Biologics
- Introduction
- Overview
- Regulatory Process
- Issues in Blood and Blood Products
- Statistical Issues in Assessing Biologic Test Kits
- Low Prevalence Conditions
- Evaluating the Safety of Blood and Blood Products
- Issues in Biologic Therapeutics
- Issues in Vaccines
- Pharmacogenetics and Drug Development
- Bioterrorism Products
- Websites for FDA Information and Guidance Documents
- Conclusion
- References
Abstract
Biologics comprise products of wide-reaching public health impact, such as vaccines, as well as products, like gene therapies, that are on the cutting edge of science. This entry reviews the basic tenants of biologics and discusses some of the issues and regulatory processes in biologic products.
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