Mediford Corporation engages in regulatory studies under GLP for pharmaceuticals, agrochemicals, general chemical products and other related products. Utilizing our extensive experience, we also support various GLP studies in response to new registrations and petitions overseas including the US and EU countries. We also conduct non-regulatory studies such as various screening tests, tests for preparation of SDS, and non-standard experiments.
Feel free to contact us regarding tests with unconventional methods.
We detect mutagenicity as an indicator of mutation from a mutant to a revertant strain We are also able to conduct studies according to the ICH guideline of genotoxicity studies. In addition to GLP studies, we also have extensive experience in screening studies. Strains used: Salmonella typhimurium, Escherichia coli (E. coli)
We prepare chromosome specimens and evaluate chromosomal aberrations by microscopic observation.
In vitro chromosome aberration tests are available using CHL/IU cells, which are widely used in Japan and abroad in compliance with the ICH guideline.
An in vitro micronucleus test is a method of detecting chromosomal abnormality through the frequency of appearance of a micronucleus in cells. This test has been put into practice worldwide due to its OECD guideline being adopted in 2010 and published in the revised ICH guidance in 2011. Within the international trend recommending the application of cells with normally functioning p53 genes, we have extensive background data of tests using not only CHL/IU cells but also TK6 cells with normally functioning p53 gene.
We evaluate chromosome aberration induction using micronucleus induction in juvenile erythrocytes from bone marrow or peripheral blood as an indicator. This assay can detect aneuploidy inducers and has the advantages of easier observation and longer detectable period of abnormality compared to chromosome aberration tests, and can be incorporated into general toxicity tests.
Clients may select a bone marrow (peripheral blood) micronucleus assay with a wide range of administration periods, i.e. from short-term (single or twice) to a 28-day repeated dosing, that corresponds with the genotoxicity study ICH guideline revised in 2011. With our abundant background data, we are also able to integrate bone marrow/peripheral blood micronucleus assays into a general toxicity studies to comply with the ICH and OECD guidelines.
The liver micronucleus assay is a test system using the liver that corresponds to the second in vivo test of the ICH guideline and is useful for the detection of genotoxic substances that require metabolic activation in the liver. This assay is more sensitive at detecting hepatocarcinogens which has been found to be difficult to detect with a bone marrow/peripheral blood micronucleus assay. Due to our extensive experience, we are able to conduct the assay using a repeated-dose regimen. In addition, we are also able to integrate this assay into a general toxicity study to comply with the ICH guideline.
An in vivo mammalian alkaline comet assay (comet assay) is used for detection of preliminary DNA strand breaks in single cells or nuclei isolated from multiple tissues including non-dividing cells. The comet assay has high sensitivity to genotoxic carcinogens and high specificity for noncarcinogens and has been accepted as a second in vivo genotoxicity study in the ICH-S2(R1) guideline when an in vitro genotoxicity study is judged positive. Due to our extensive experience, we are able to conduct this assay according to the OECD guideline. In addition, we have abundant background data of the liver and glandular stomach related to this assay. Please feel free to contact us for more details of the above or other organs/tissues.
We have the expertise to conduct a combination study of the bone marrow micronucleus test and comet assay simultaneously using the same animal. The combination study reduces the number of animals used and shortens the study period without reducing the maximum dose level. This technique has been highly acclaimed at IWGT (International Workshops on Genotoxicity Testing).
We conduct a gpt assay using gpt mice. This assay is mainly used for follow-up of positive results of Ames test and is compliant with the ICH M7 guideline.
The above studies are able to be conducted under non-GLP compliance or with other preliminary methods.
Please feel free to contact us regarding the study designs and other related topics.