For Genotoxicity
Determine if your substrate will influence genetic material or have hazardous affects through genotoxicity testing. Compounds identified as genotoxic have the potential to be human carcinogens and/or mutagens which can cause cancer and/or defects. Genotoxicity is a requirement prior to the approval of any new drug. CMIC conducts these studies using a small amount of a test compound expeditiously in initial screening and conducts hepatocyte micronucleus assay in juvenile rats as a second in vivo micronucleus assay.
Ames Test
The Ames test evaluates the potential of a test compound to induce the reverse mutations in bacteria. The Ames test is in compliance with the principles of GLP in accordance with the Industrial Safety and Health Law GLP and the Act on the Evaluation of Chemical Substances and Regulation of Their Manufacture. Ames test are conducted during screening, IND enabling studies and impurity assessments.
Our Edge in Genotoxicity Studies
Efficient Use of Test Compounds
Conduct genotoxicity testing using a small amount of test compound expeditiously during initial screening.
Specialty Assays
Ability to conduct micronucleus assay in juvenile rats as a second in vivo micronucleus assay.
In Vitro & In Vivo Services for Genotoxicity
Studies | Service | Note |
Ames Test
|
Pharmaceuticals GLP | OECD TG 471
Genotoxicity testing (ICH S2) Genotoxic impurities (ICH M7) |
Medical Devices GLP | ISO-10993-3
Medical device guidelines |
|
Industrial Safety and Health Act GLP | OECD TG 471
Preparation Submission forms (For domestic application) |
|
Chemical Substances GLP | OECD TG 471
Preparation Submission forms (For domestic application) |
|
Culture Cell Tests
|
Thymidine Kinase assay(MLA) | OECD TG 490
Mouse lymphoma (L5178Y), human lymphoblastoid cell (TK6) |
Chromosomal aberrations test | OECD TG 473
Cultured cells (CHL/IU) |
|
Micronucleus test | OECD TG 487
Cultured cells (CHL/IU, TK6) |
|
In Vivo Tests
|
Micronucleus test | OECD TG 474
Mice and rats (hematopoietic cells) |
Micronucleus test | Juvenile rats (hepatocytes) | |
Chromosomal aberration | OECD TG 475
Rats (hematopoietic cells |
|
Screening Services | Optimal test design enables low cost and speedy test |