Robert Powell, Head of Pharmacometrics in FDA's Office of Clinical Pharmacology. "This agreement is concrete evidence of the FDA's commitment to the Critical Path Initiative," said Dr. "With the increasing costs of new drug development, the FDA recognizes the importance of utilizing innovative technologies, including Pharsight's data management and modeling and simulation tools, to accelerate review and increase the number of new, safe and effective therapies available to patients." "This collaboration between Pharsight and FDA supports the Critical Path initiative to improve the productivity and efficiency of the drug development process," said Shawn O'Connor, president and chief executive officer of Pharsight. Pharsight will utilize the FDA's feedback from the collaboration to further develop and customize PKS to meet industry analysis requirements, and further develop DMX to support Agency-sponsor interactions for the visualization and communication of model-based product profiles. The purpose of the collaboration is to develop PKS into a repository for the data needed for modeling and simulation, support Clinical Data Interchange Standards Consortium (CDISC) data formats, and interact with other FDA databases. The collaboration directly supports the FDA's Critical Path Initiative, which advocates increased use of drug-disease modeling and simulation to improve the efficiency of the drug product development process.
#Winnonlin support software
Pharsight will make available a comprehensive suite of software tools, including Pharsight Knowledgebase Server™ (PKS™), PKS Validation Suite™, WinNonlin ® Validation Suite™, Drug Model Explorer™ (DMX ®) and Pharsight Trial Simulator™.įDA will use the Pharsight tools to review clinical trial data, especially for clinical pharmacology and clinical safety reviews, and will provide feedback to Pharsight. Under the terms of the CRADA, Pharsight will collaborate with FDA using Pharsight software for the analysis, visualization, storage, reporting and review of pharmacokinetic/pharmacodynamic data.
Pharsight Corporation has announced that it has entered into a Cooperative Research and Development Agreement (CRADA) with the Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER).
0 kommentar(er)
