Related Experiment Video
Updated: Dec 18, 2025
MEDUSA for Identifying Death Regulatory Genes in Chemo-genetic Profiling Data
Published on: February 7, 2025
Use of "Big Data" to Evaluate Responses to Changes in Regulatory Guidelines: Trends in Genotoxicity Testing Packages
Lesley Reeve1, Paul Baldrick2, Andrew Newell2
1Covance Laboratories Ltd, Otley Road, Harrogate, North Yorkshire, HG3 1PY, UK. Lesley.reeve@covance.com.
Background:
In 2006, a concept paper (ICH S2(R1)) describing the need for revision of the ICH guidelines on genotoxicity testing for new "small molecule" pharmaceuticals (then ICH S2A and ICH S2B) was finalised. As a result, testing strategy has changed, and flexibility has been introduced in the form of two "equally suitable" options for completing the battery of genotoxicity studies required to support clinical development and marketing of new products.
Methods:
The TIBCO Spotfire® platform was used to create a specific view of available in-house data on genotoxicity studies conducted to support pharmaceutical product development over a period of approximately 12 years. The available in-house dataset comprised all reportable non-clinical data from Good Laboratory Practice (GLP) compliant and non-GLP/screening studies on regulated products (including pharmaceuticals, industrial chemicals, agrochemicals, and medical devices) across multiple testing sites, in different geographical locations.
Results:
The analysis showed clear trends in the numbers and types of genotoxicity studies conducted on small molecule pharmaceutical products during development, which correlated with the changes in the available regulatory guidance over time. More interestingly, where two "equally suitable" options for genotoxicity testing are described in the international guidance, there is a clear preference for ICH S2(R1) Option 1 (70-80% of testing) compared to Option 2 (20-30%).
Conclusion:
Use of 'Big Data' identified trends in the newer approach to genotoxicity testing by industry in the light of the updated regulatory guidance.
More Related Videos
17:28Human Pluripotent Stem Cell Based Developmental Toxicity Assays for Chemical Safety Screening and Systems Biology Data Generation
Published on: June 17, 2015
16:02Demonstration of the Sequence Alignment to Predict Across Species Susceptibility Tool for Rapid Assessment of Protein Conservation
Published on: February 10, 2023
Related Concept Videos
01:25Drug Regulation
01:25Mutagenicity and Carcinogenicity
02:46Genetic Screens
Forward genetic screens
Forward or “classical” genetic screens involve creating random mutations in an organism’s DNA using radiation, mutagens, or insertion of additional bases, which...
01:24Dosage Regimen: Individualization
01:23Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
01:19Pharmacovigilance
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...