| Article ID | Journal | Published Year | Pages | File Type |
|---|---|---|---|---|
| 33592 | New Biotechnology | 2011 | 8 Pages |
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.
Related Topics
Physical Sciences and Engineering
Chemical Engineering
Bioengineering
Authors
Paul Chamberlain,