Navigating new regulatory guidelines for drug metabolism studies

Scientists strategically design programs to detect red flags early in drug development, saving time and money by prioritizing top drug candidates.

Regulatory agencies require scientists to perform multiple in vitro studies to predict a new drug’s safety and efficacy, which includes determining potential interactions between the new compound and other medications. However, previously disparate regional requirements made it difficult for researchers to ensure their study design complied with global federal agency regulations. Starting in 2024, drug developers will follow the new unified Drug Interaction Studies Guidelines (M12) developed by the International Council for Harmonization (ICH). 

Download this ebook from BioIVT to learn how to navigate the recently unified regulatory guidelines and optimize drug development by eliminating unnecessary experiments and reducing regulatory barriers on a global scale.

Sponsored by