Optimization of human absorption, metabolism, and excretion (hAME) studies, and their timing, increases the chance of drug development success, saving time and resources. This digital whitepaper provides advice and insight on how to make the right choices when planning and conducting hAME studies and how to leverage preclinical and clinical …
In vitro drug-drug interaction (DDI) regulation updates in the FDA’s 2020 guidance: A summary
In January 2020 the Food and Drug Administration (FDA) reviewed its 2017 draft content and published finalized guidance for in vitro and clinical drug interaction studies. We’ve summarized the the key changes and implications for in vitro drug-drug interactions (DDI) testing in this post, but if you would like more …