Large molecule therapies hold immense promise for treating an array of diseases, but their development presents unique challenges in preclinical testing. Toxicology studies form a cornerstone of this process, providing essential data on the drug’s biological effects. While small molecule drugs have been the focus of drug development for decades, large molecule therapies present unique challenges…
Preparing an IND submission: Here is what drug sponsors should anticipate
Before drug sponsors can conduct clinical trials of new therapeutics in the U.S., they must first receive permission from the FDA. The vehicle by which that permission is sought is an Investigational New Drug (IND) application, and once it is submitted, drug development effectively ceases until regulators approve it. The main goal of an IND…