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Evolution of a regulatory framework for pharmaceuticals derived from genetically modified plants

Paper ID Volume ID Publish Year Pages File Format Full-Text
37404 45350 2008 12 PDF Available
Title
Evolution of a regulatory framework for pharmaceuticals derived from genetically modified plants
Abstract

The use of genetically modified (GM) plants to synthesize proteins that are subsequently processed, regulated and sold as pharmaceuticals challenges two very different established regulatory frameworks, one concerning GM plants and the other covering the development of biotechnology-derived drugs. Within these regulatory systems, specific regulations and guidelines for plant-made pharmaceuticals (PMPs) – also referred to as plant-derived pharmaceuticals (PDPs) – are still evolving. The products nearing commercial viability will ultimately help to road test and fine-tune these regulations, and might help to reduce regulatory uncertainties. In this review, we summarize the current state of regulations in different countries, discuss recent changes and highlight the need for further regulatory development in this burgeoning, new industry. We also make the case for the harmonization of international regulations.

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Publisher
Database: Elsevier - ScienceDirect
Journal: - Volume 26, Issue 9, September 2008, Pages 506–517
Authors
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Subjects
Physical Sciences and Engineering Chemical Engineering Bioengineering
Get Full-Text Now
Don't Miss Today's Special Offer
Price was $35.95
You save - $31
Price after discount Only $4.95
100% Money Back Guarantee
Full-text PDF Download
Online Support
Any Questions? feel free to contact us