This webinar covers aspects of early clinical pharmacology study design and data collection that can enable successful concentration-QT (C-QT) analysis. C-QT is an internationally accepted approach used to establish the risk of prolonging the QT interval and a low-cost and efficient option compared to conducting a thorough QT (TQT) study.
C-QT analyses uses data from single or multiple ascending dose Phase 1 studies and are only as robust as the data available. At the end of this webinar, attendees should have a better understanding of:
- What C-QT analysis is and how it’s used
- How to plan study designs that best support C-QT analysis
- Overview of nonclinical and clinical integrated risk assessment
- Clinical scenarios that require more vigorous nonclinical evaluation of cardiac risk
Meet the Presenter
Lauren R. L. Lohmer, Ph.D.
Director, Clinical Pharmacology
Dr. Lohmer has experience in all stages of development, with specific interest in concentration-QT analysis. She has worked on over 20 approved drugs and numerous NDAs, INDs, protocols, PK analyses, and population PK analyses. Dr. Lohmer’s PK and PK/PD experience covers nonclinical, clinical, and post-marketing for an extensive range of therapeutic areas and a wide variety of regulatory interactions, regulatory meetings, and regulatory submissions.