Guidance on Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Use Step 3 NOTE FOR GUIDANCE ON GENOTOXICITY TESTING AND DATA INTERPRETATION FOR PHARMACEUTICALS INTENDED FOR HUMAN USE (EMEA/CHMP/ICH/126642/2008) APPROVAL BY CHMP

ICH guideline S2 (R1) - Genotoxicity testing and data interpretation for pharmaceuticals intended for human use

Combining the in vivo comet and micronucleus assays: a practical approach to genotoxicity testing and data interpretation

Despite regulatory directives requiring the reduction of animal use in safety testing, recent modifications to genotoxicity testing guidelines now propose the use of two in vivo genotoxicity assays as a follow-up to an in vitro positive (International Conference on Harmonization Consensus Draft Guidance S2[R1] released March, 2008). To address both goals, the in vivo comet and micronucleus (MN)...

A Novel Strategy to Predict Carcinogenicity of Antiparasitics Based on a Combination of DNA Lesions and Bacterial Mutagenicity Tests

Genotoxicity and carcinogenicity testing of pharmaceuticals prior to commercialization is requested by regulatory agencies. The bacterial mutagenicity test was considered having the highest accuracy of carcinogenic prediction. However, some evidences suggest that it always results in false-positive responses when the bacterial mutagenicity test is used to predict carcinogenicity. Along with maj...

Recommendations for conducting the in vivo alkaline Comet assay. 4th International Comet Assay Workshop.

The in vivo alkaline single cell gel electrophoresis assay, hereafter the Comet assay, can be used to investigate the genotoxicity of industrial chemicals, biocides, agrochemicals and pharmaceuticals. The major advantages of this assay include the relative ease of application to any tissue of interest, the detection of multiple classes of DNA damage and the generation of data at the level of th...

Evaluating, interpreting, and communicating performance of hydrologic/water quality models considering intended use: A review and recommendations

Previous publications have outlined recommended practices for hydrologic and water quality (H/WQ) modeling, but limited guidance has been published on how to consider the project’s purpose or model’s intended use, especially for the final stage of modeling applications e namely evaluation, interpretation, and communication of model results. Such guidance is needed to more effectively evaluate a...