The ability to predict outcomes is relevant in many industries, yet it is particularly relevant to the benefits of predictive toxicology testing within drug safety. The ability to use scientific approaches to understand, predict and prevent adverse effects underpins the development and release of drugs for patient use.
Early-stage assessment
Toxicology testing enables successful drug discovery through the early-stage assessment of genotoxicity. Tools such as those offered by Gentronix, leading experts in predictive toxicology, allow qualitative and Yes/No hazard determination alongside informative mode-of-action review to support clients seeking toxicology assurances when developing new drugs. Highly accurate predictions of regulatory outcomes are possible.
In vivo genetic effects can be assessed using a variety of informative tests and software to inform scientists and drug manufacturers.
Cutting costs and providing better outcomes
The cost of bringing drugs to market and obtaining regulatory approval is vast. It takes many years; one significant problem being late-stage failures and the rising costs of failing drugs, with as many as 90% of drugs not reaching regulatory assessment or making it to the approved drugs list. Drug safety is responsible for around a third of overall failures.
Predictive toxicology testing can reduce and remove many late-stage failures using early insights and combined knowledge from all science fields to predict outcomes. Late-stage losses are reduced by early observation of adverse genotoxicity results. In this way, toxicologists can assess risks and make an early assessment of the viability of drugs and eventual program success.
Assay testing offers a high scientific quality that delivers the most appropriate endpoints, with result data that can be interpreted and used to inform future drug development.
Genetic toxicology
Genotoxicity is a set of modes of action that can lead to inherited mutations, cancers or diseases. The drug safety process must evaluate the possibility that a new chemical or product could be harmful, even when it is being created to do good. Genotoxic substances will either permanently alter DNA or the ability of a cell to regulate the content and structure of DNA.
Using assay test screening ensures that chemicals used within drug development enable statistical prediction of mechanisms using machine learning strategies across multiple compounds in methods consistent with regulatory batteries, responsive timelines and minimal test materials. Positive results can be identified as either a clastogenic or aneugenic mechanism, providing valuable information to inform further courses of action.
Receiving a comprehensive prediction of genetic toxicology during the early stages of drug discovery enables quick and accurate results to reduce the time and money spent pursuing non-viable courses of action.
Non-animal testing
The requirement to reduce and remove the use of animals in testing has made using emerging technologies essential to ensure that new drug development can continue safely and forecast the effects of the chemicals on humans. Predictive toxicology strategies reduce the costly and lengthy reliance on animal studies. Iterative read-across evaluations use predictive software programs to interpret and characterize hazards.
When carried out in the early stages, it is possible to interpret results and go on to make use of further risk assessments. Adverse outcome pathways can be utilised with valuable mode-of-action data that can be tailored to meet specific client and drug requirements.
When we can predict, assess and adapt drug safety toxicology profiles, it enables toxicologists to more quickly and reliably bring drugs to the market, we can be sure to benefit from new drug developments without fear that the latest and most exciting development will cause problems later down the line.
