E-resources
Peer reviewed
-
Hoffmann, Sebastian; Peterbauer, Anja; Schindler, Stefanie; Fennrich, Stefan; Poole, Stephen; Mistry, Yogesh; Montag-Lessing, Thomas; Spreitzer, Ingo; Löschner, Bettina; van Aalderen, Mirjam; Bos, Rogier; Gommer, Martin; Nibbeling, Ria; Werner-Felmayer, Gabriele; Loitzl, Petra; Jungi, Thomas; Brcic, Marija; Brügger, Peter; Frey, Esther; Bowe, Gerard; Casado, Juan; Coecke, Sandra; de Lange, Jan; Mogster, Bente; Næss, Lisbeth M.; Aaberge, Ingeborg S.; Wendel, Albrecht; Hartung, Thomas
Journal of immunological methods, 03/2005, Volume: 298, Issue: 1Journal Article
It is a requirement that parenteral medicines be tested for pyrogens (fever causing agents) using one of two animal-based tests: the rabbit pyrogen test and the bacterial endotoxin test. Understanding the human fever reaction has led to novel non-animal alternative tests based on in vitro activation of human monocytoid cells in response to pyrogens. Using 13 prototypic drugs, clean or contaminated with pyrogens, we have validated blindly six novel pyrogen tests in ten laboratories. Compared with the rabbit test, the new tests have a lower limit of detection and are more accurate as well as cost and time efficient. In contrast to the bacterial endotoxin test, all tests are able to detect Gram-positive pyrogens. The validation process showed that at least four of the tests meet quality criteria for pyrogen detection. These validated in vitro pyrogen tests overcome several shortcomings of animal-based pyrogen tests. Our data suggest that animal testing could be completely replaced by these evidence-based pyrogen tests and highlight their potential to further improve drug safety.
Author
![loading ... loading ...](themes/default/img/ajax-loading.gif)
Shelf entry
Permalink
- URL:
Impact factor
Access to the JCR database is permitted only to users from Slovenia. Your current IP address is not on the list of IP addresses with access permission, and authentication with the relevant AAI accout is required.
Year | Impact factor | Edition | Category | Classification | ||||
---|---|---|---|---|---|---|---|---|
JCR | SNIP | JCR | SNIP | JCR | SNIP | JCR | SNIP |
Select the library membership card:
If the library membership card is not in the list,
add a new one.
DRS, in which the journal is indexed
Database name | Field | Year |
---|
Links to authors' personal bibliographies | Links to information on researchers in the SICRIS system |
---|
Source: Personal bibliographies
and: SICRIS
The material is available in full text. If you wish to order the material anyway, click the Continue button.