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Technical Documents
Copyright© 2003-2010 Helix3 Inc.  All Rights Reserved
 
Regulatory Guidelines
Low Molecular Weight DNA Diffusion Assay

CFDA / EtBR Dual Stain Viability Assay


Guidance on Genotoxicity Testing and Data Interpretation for Pharmaceutical Intended for Human Use S2(R1) (2008)

FDA Recommendations for the Integration of Genetic Toxicology Study Results (k)

COM Guidance for Chemical Mutagenicity Testing (2000)

ICH Guidelines for Standard Battery of Genotoxicity Testing (1997)
Helix3 Publications
Journal Articles:

Combining the In Vivo Comet and Micronucleus Assays:  A Practical Approach to Genotoxicity Testing and Data Interpretation (Mutagenesis 2009)

The Comet Assay as an Indicator Test for Germ Cell Genotoxicity (Mutat Res 2009)

Fourth International Workgroup on Genotoxicity Testing:  Results of the In vivo Comet Assay Workgroup (Mutat Res 2007)



Helix3 Poster Presentations:

Combining the In Vivo Comet and Micronucleus Assays:  A Practical Apprpoach to Genotoxicity Testing and Data Interpreatation (EMS 2009)

The Combined In Vitro and Acellular Comet ASsay:  Understanding Mechanisms of Genotoxicity (EMS 2009)

The Comet Assay:  Breaking from Tradition (EMS 2008)

Interpreting Data from in Vitro Genotoxicity Tests Using the Acellular Comet Assay (EMS 2008)

Target Organ Selection for the In Vivo Comet Assay:  Genotoxicity Versus Turmorigenesis (EMS 2008)

Safety Testing with the in Vitro Comet Assay:  Critical Factors in Protocol Design and Data Interpretation (EMS 2007)

Cytotoxicity and its Impact on the In Vivo k Assay (EMS 2007)

Effects of Sample Processing on the Interpretation of In Vivo Comet ASsay Data (EMS 2006)