Related Resources
®SCS Capabilities — PK/PD Modeling and Analysis
Insufficient PK/PD knowledge is one of the primary factors in the 80% attrition rate reported by the FDA for New Chemical Entities (NCE) in clinical development (Source: “Innovation or Stagnation: Challenge and Opportunity on the Critical Path to New Medical Products”, FDA, March 2004).
PK/PD modeling and analysis includes design and analysis of efficacy and
safety measures for a development compound, such as biomarkers, surrogate
endpoints, and true clinical endpoints.
Pharsight's experience with modeling QTc prolongation, as an important and increasingly scrutinized safety measure of cardiac arrhythmic risk, spans several classes of drugs and multiple indications. We have specific expertise in linking drug population pharmacokinetics to QTc prolongation response, Fourier modeling of diurnal rhythm, extrapolating pre-clinical results to the clinical setting, and trial design of QTc studies.
Knowledge of PK/PD is fundamental for dose-selection and can provide justification for bridging clinical data between populations, (including Japanese and Western populations), indications, or regions. Successful bridging can lead to earlier launch and stronger commercial success.