Renal and Hepatic Impairment Studies: Optimizing Strategies in Clinical Development Webinar

From study design to feasibility assessment to patient enrollment, many important considerations factor into achieving timely completion of renal/hepatic impairment studies. As traditional renal and hepatic impairment studies have shifted, efficiently conducting these studies to understand the effect of a treatment and achieve regulatory approval requires a comprehensive, cross-functional strategy. Watch this webinar to hear from four specialists in the field as they share their insights for optimizing a clinical development plan, identifying key protocol parameters, best practices for managing the medical and scientific aspects of impairment studies, how to choose the right sites and perform startup quickly. They will also cover practical considerations for handling the complexity of Phase I studies, conducting a "reduced PK study" per the FDA guidance and working with dialysis cohorts.