Text Box: Through our model-based approach to drug development, GLDD maximizes the informativeness of all relevant data (internal, external, pharmacology) leading to early and more confident data driven decisions and support of these decisions with regulators.

q FDA  “Innovation or Stagnation” report (2004) advocated the use of model-based drug development to improve development efficiency, avoid late stage attrition

q FDA recognizes trial planning may be improved by clinical trial simulations that employ quantitative models of drug dose-response, placebo effect, and disease progression.

q FDA End-of-Phase IIa guidance recommends model-based approaches to facilitate decisions regarding dose selection and subsequent clinical trial designs 

Text Box: Model-Based Drug Development Text Box: Pharmacometrics

q Pharmacometrics is an integration of statistics & pharmacology, focused on the application of PK-PD based population modeling & simulation to aid decision making