Meet ICH Requirements & Lower Safety Endpoint Risks
You need to meet the regulatory requirements of the ICH core battery studies. But what about your own business risks? With many compounds, it’s possible to clear ICH hurdles only to face a host of safety endpoint issues as you advance from discovery, through early development and into clinical study phases. You need a value-added partner to help identify unsafe compounds earlier than ever before.
Access Endpoints During Toxicology Studies
By looking at safety pharmacology through a business risk lens, you begin to see the process of safety assessment in an entirely different light. Now you can economically assess your endpoints during your toxicology studies to make better safety predictions, earlier than ever before. With many compounds running into safety issues during the clinical phases, there is a great opportunity to anticipate these data in your nonclinical stage, saving you time and money long-term. By better understanding and reducing the risk of drug attrition of your molecule, you are able to progress forward with more confidence — and with the right molecules. Rethink what’s possible and gain a markedly different approach to your early safety assessment regimen.