New Options for TQT Waivers from First-in-Human and Oncology Phase I Studies Webinar Replay
In this webinar replay, Dr. Borje Darpo and Dr. Robert Kleiman will describe how the new ICH S7B/E14 revisions open up new opportunities for drug developers and discuss on-going trends in First-In-Human ECG studies. The speakers will dive into various case studies and look at the impacts of early-stage QT assessment given positive and negative results as well as the context of the drug development project. Additional consideration will be given to best practices with non-clinical hERG assays and in vivo QT studies as well as Section 6.1 of the guidance, covering drugs such as oncologics.
Watch this webinar replay to learn about new developments that enable easier TQT waivers from early phase heathy volunteer and oncology studies.