## As an initial consideration for use of TM assays in a regulatory submission, we focus here especially on the following questions: (1) What conditions would trigger the performance of a TM assay? (2) What data set is sufficient to support a negative result? and (3) What increase in mutation freq
Prospects for safety testing: A strategy for the application of transgenic rodent mutagenesis assays
β Scribed by Nancy J. Gorelick; Jon C. Mirsalis
- Publisher
- John Wiley and Sons
- Year
- 1996
- Tongue
- English
- Weight
- 999 KB
- Volume
- 28
- Category
- Article
- ISSN
- 0893-6692
No coin nor oath required. For personal study only.
β¦ Synopsis
The past several years have seen an enormous increase in the development and use of transgenic animal models to measure mutations in specific inserted reporter genes. These systems provide gene mutation data in vivo in a wide range of relevant tissues. Numerous laboratories are now using these systems with consistent results. This paper describes the unique niche that transgenic mutagenesis systems can fill in product development and registration strate gies. In addition to tissuespecific mechanistic studies, transgenic assays are available to follow up mutagenic effects demonstrated in Salmonella, Escherichia coli, mouse lymphoma (El 78y) cells, or other in vitro systems.
π SIMILAR VOLUMES
## Abstract The pharmacokinetics of intracellular drugs have recently aroused new interest because monitoring a drug's behaviour near the site of action can enhance knowledge of its efficacy and toxicity. Liquid chromatography coupled with tandem mass spectrometry (LC/MS/MS) is particularly attract