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

StudiesServiceNote

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 testJuvenile rats (hepatocytes)
Chromosomal aberration

OECD TG 475

Rats (hematopoietic cells

Screening ServicesOptimal test design enables low cost and speedy test

Non-Clinical Studies

Toxicity

Safety Pharmacology Studies

Efficacy Pharmacology Studies