New Options For TQT Waivers From First-In-Human And Oncology Phase I Studies

In this webinar replay, Dr. Borje Darpo and Dr. Robert Kleiman describe how the new ICH S7B/E14 revisions open up new opportunities for drug developers and discuss ongoing trends in First-In-Human ECG studies. The speakers dive into various case studies and look at the impacts of early-stage QT assessment given positive and negative results and the context of the drug development project. Additional consideration is also 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.

Access the webinar to learn about new developments that enable more accessible TQT waivers from early-phase healthy volunteer and oncology studies.