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Pre-clinical strategies and safety issues in developing therapeutic monoclonal antibodies

Paper ID Volume ID Publish Year Pages File Format Full-Text
33592 44986 2011 8 PDF Available
Title
Pre-clinical strategies and safety issues in developing therapeutic monoclonal antibodies
Abstract

Although mAbs present a different set of challenges from other product classes, and the pre-clinical safety evaluation may need to be more extensive than for other medicinal products to overcome the limited predictive value of conventional pre-clinical test systems, the level of risk associated with first administration to human subjects can be effectively mitigated.This article seeks to provide a systematic approach to identifying and addressing the pertinent risks relative to the characteristics of the particular mAb product before the first administration to human subjects.

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Pre-clinical strategies and safety issues in developing therapeutic monoclonal antibodies
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Publisher
Database: Elsevier - ScienceDirect
Journal: New Biotechnology - Volume 28, Issue 5, September 2011, Pages 481–488
Authors
,
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
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Full-text PDF Download
Online Support
Any Questions? feel free to contact us