LSIM Safety Institute 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, exam for MSDS making, and non-standard experiments.
Feel free to contact us regarding background data of various studies, actual results of entrustments, or any other related inquiry.
We are also able to conduct studies according to the ICH guidance of genotoxicity studies. In addition to GLP studies, we also have extensive experience in screening studies.
We generally conduct in vitro chromosomal aberration studies according to ICH guidance of genotoxic studies with CHL/IU cells or human lymphocyte cells which are widely used worldwide.
An in vitro micronucleus test is a method of detecting chromosomal abnormality through the frequency of appearance of a micronucleus in cells. It is believed that this test will be 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.
Our clients may select a bone marrow (peripheral blood) micronucleus assays with a wide range of administration periods, i.e. from short-term (single or twice) to a 28-day repeated dosing, that correspond with the genotoxicity study ICH guidance 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 guidance or OECD guidelines.
A liver micronucleus assay (LM assay) is more sensitive at detecting hepatocarcinogens which has been found to be difficult to detect with a bone marrow/peripheral blood micronucleus assay. We recommend the LM assay as a second in vivo genotoxicity study to comply with the ICH guidance. Due to our extensive experience, we are able to conduct the assay with a partial hepatectomy, using juvenile rats and a repeated-dose regimen. In addition, we are also able to integrate the LM assay into a general toxicity study to comply with ICH guidelines due to our extensive background in the field.
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 is accepted as a second in vivo genotoxicity study in the ICH-S2(R1) guidance when an in vitro genotoxicity study is judged positive. Due to our extensive experience which includes participation in the International Validation of Collaborative Study of the in vivo Comet assay, 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. 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. A 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 provide information for clients concerning development of pharmaceuticals, agrichemicals, and chemical substances etc.
Please note and understand that we cannot respond to requests from competitors or free e-mail addresses.
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