Safe drug delivery relies on testing. Testing is carried out to ensure that new drugs and vaccines used for human treatment are safe and that their potential benefits and harmful side effects are studied and understood.
Safety studies ensure developers can identify hazards and discard candidate molecules and associated risks, ensuring that only the safest profiles progress to human clinical trials.
Using animal models to support safe drug and vaccine delivery is essential to the testing before drugs are submitted for trials and regulatory approval.
Cardiovascular side effect identification
Cardiovascular side effects are a common cause of drug molecule deselection in early drug development. Even a slight increase in arterial blood pressure caused by medication can significantly increase the risk of stroke or heart attack. Drug-induced arrhythmia, a disturbance to the heart’s normal rhythm, can be caused by some drugs. Before undertaking human clinical trials, it is essential to make informed decisions about risk/reward ratios through a thorough understanding of each drug’s mechanisms and safety profiles.
Rat telemetry assays, part of the drug discovery services offered by companies such as Vivonics, a contract research organisation specialising in testing the effects of potential new drugs on vital organ function, are an essential step in the process. Rodent telemetry is used in the early stages of new medicine discovery to ascertain the effects and assess cardiovascular risk. An expert range of validated in vivo assays is crucial to identifying and interpreting the efficacy and safety of drugs early in the process and will inform future development.
Rat telemetry as a reliable indicator
Early rat telemetry assay testing can be followed by large animal testing before human volunteers and patients undergoing clinical trials. The effects of new drugs on arterial blood pressure and heart rate must be tested in a non-rodent species, usually using implanted telemetry devices.
Data has established a reliable link for drug-induced cardiovascular risk from rats to larger animal species with a high results agreement. The study showed that a drug showing an effect in the rat telemetry assay has a 90% chance that it will also show in larger animal species. The data has also been studied, and calculated the predictive negative and positive values of the rat telemetry assage. These study datasets also support a high degree of concordance between humans and large animals, with sensitivity and specificity values approaching 80%.
Informing the future
Understanding the risks and rewards can make decisions on understanding the inherent drug target risks and make informed decisions on whether to progress with further work, make early changes, or discontinue development. Testing using the rat telemetry assay is a valuable tool for giving reliable and cost-effective testing solutions to identify early in the drug discovery process any risks that may be present. These results enable early decisions on the future development potential of the molecules and chemical series.
Fully transplantable telemetry devices
Test animals can be kept in conditions more like their natural habitats. Animals can be kept in freely moving groups and are not subjected to excessive handling during the test and results acquisition. Less human handling and intervention to collect the required data causes less stress and more natural results, with multiple cardiovascular parameters managed simultaneously by conscious animals without disturbance.
Using a telemetry device transplanted into the rodent allows a better life for the test animals. We live in a world where we can not completely eradicate the need for small animal testing to ensure that drugs that go on to human regulatory approval are safe. Still, we must ensure that we do all we can to reduce the effects and harm to test animals. Improving the mechanisms to collect a wide range of results from the animals through the use of rat telemetry assays provides these solutions.