Transgenic Models in Drug Discovery: An Industrial Perspective

✍ Scribed by Patrick Hardy

• Publisher: John Wiley and Sons
• Year: 1997
• Tongue: English
• Weight: 126 KB
• Volume: 2
• Category: Article
• ISSN: 1087-8378
• DOI: 10.1002/(sici)1099-1786(199703)2:1<19::aid-qaj20>3.0.co;2-w

✦ Synopsis

The Research and Development activities in the pharmaceutical industry and other biomedical arenas are turning increasingly to the use of specifically developed animal models, frequently the result of genetic manipulation. These transgenic animals will become a constant part of the environment in R&D worldwide. This short article highlights some of the important general issues surrounding the use of such animals and the quality concerns relating to their creation and maintenance. This is necessary background information for the quality assurance professional working with scientists who deal with these models and wishing to contribute to the establishment of high standards of good practice. In particular QA has a role in the review of contract specifications to ensure that the expectations of sponsors and suppliers are well met.