Initial Consideration for Use of Transgenic Mutation Assays in a Regulatory Submission

Environmental and Molecular Mutagenesis

Volumn 28, Issue 4, 1996, Pages 443-446

  Sofuni, Toshio ^a   Suzuki, Takayoshi ^a   Hayashi, Makoto ^a  

^a NATIONAL INSTITUTE OF HEALTH SCIENCES   (Japan)

Author keywords

Regulatory submission; Transgenic mutation assay

Indexed keywords

ANIMALIA;

MUTAGENIC AGENT;

ANIMAL; ARTICLE; DOSE RESPONSE; GENETICS; METHODOLOGY; MUTAGEN TESTING; MUTATION; PRACTICE GUIDELINE; REFERENCE VALUE; STANDARD; TISSUE DISTRIBUTION; TRANSGENIC ANIMAL;

ANIMALS; ANIMALS, GENETICALLY MODIFIED; DOSE-RESPONSE RELATIONSHIP, DRUG; GUIDELINES; MUTAGENICITY TESTS; MUTAGENS; MUTATION; REFERENCE VALUES; TISSUE DISTRIBUTION;

EID: 0030337974     PISSN: 08936692     EISSN: None     Source Type: Journal    
DOI: 10.1002/(SICI)1098-2280(1996)28:4<443::AID-EM21>3.0.CO;2-E     Document Type: Article

References (6)

1. Carr GJ, Gorelick NJ (1995): Statistical design and analysis of mutation studies in transgenic mice. Environ Mol Mutagen 25:246-255.
2. Gorelick NJ (1995): Overview of mutation assays in transgenic mice for routine testing. Environ Mol Mutagen 25:218-230.
3. Gossen JA, DeLeeuw WJF, Tan CHT, Zwarthof EC, Berends F, Lohman PHM, Knook DL, Vijg J (1989): Efficient rescue of integrated shuttle vectors from transgenic mice: A model for studying gene mutations in vivo. Proc Natl Acad Sci USA 86:7971-7975.
4. Morrison V, Ashby J (1994): A preliminary evaluation of the performance of the Muta™ Mouse (lacZ) and Big Blue™ (lacl) transgenic mouse mutation assays. Mutagenesis 9:367-375.
5. Piegorsch WW, Margolin BH, Shelby MD, Johnson A, French JE, Tennant RW, Tindall KR (1995): Study design and sample sizes for a lacl transgenic Mouse mutation assay. Environ Mol Mutagen 25:231-245.
6. Short JM, Kohler SW, Provost GS, Fieck A, Kretz PL (1990): The use of a lambda phage shuttle vector in transgenic mice for development of a short-term mutagenicity assay. In Mendelsohn ML, Albertini RJ (eds): "Mutation and the Environment." part A. New York: Wiley-Liss, pp 355-367.