Month: September 2016
FDA’s New Module 1 is a Bridge to eCTD 4
Editor’s note: Jason Rock served as Project Lead for the HL7 RCRIM Expert Working Group that developed the Regulated Product Submissions (RPS) standard. This post is the third in a series on the Next Major Version (NMV) of eCTD, eCTD 4, which is based on the RPS standard. The evolution of the Electronic Common Technical … Continued
Arming Adherence-based Drug Development with Pharmacometrics
The time is right to explore how sensor-enabled digital adherence monitoring systems can benefit patients, sponsors, and payers. Non-adherence to prescribed medications is a key issue facing our healthcare industry, costing the US healthcare economy between $100-300 billion annually, representing between 3-10% of total healthcare costs.1,2 Further, non-adherence also decreases our ability to capture dose-response … Continued
Phoenix NLME，面向当今科学家的现代 PK/PD 建模软件
Phoenix NLME is the PK/PD modeling software that is user-friendly and easy-to-learn. Built from the ground up on the Phoenix workbench architecture, Phoenix NLME enables users to focus on modeling, and not on the tools or coding required to implement the modeling. The result is more time for analysis and strategic decision-making.
In Silico Assessment of Antiarrhythmic Effects of Drug Ranolazine on Electrical Activity in Human Ventricular Myocardium
D360 Express 科学数据信息中心
D360 Express is an out-of-the-box integrated solution specifically designed for discovery scientists at smaller pharmaceutical research organizations. It provides access, integration, analysis and visualization of scientific data from multiple data sources. D360 Express gets you up and running quickly and affordably.
Certara Acquires d3 Medicine
PRINCETON, NJ – Sept 7, 2016 – Certara, the leading provider of decision support technology and consulting services for optimizing drug development and improving health outcomes, today announced that it has acquired d3 Medicine.
The Role of a U.S. Agent
Foreign sponsors of drug applications who want to conduct business in the United States need an authorized U.S. Agent to interact with the FDA on their behalf. Expectations for the individual or company serving as the U.S. Agent should go beyond forwarding email and monitoring the fax machine. The U.S. Agent should add value in … Continued
