Year: 2018
Predicting Depth Resolved Concentrations in the Dermis Using PBPK Modeling: Design, Development and Verification of the Model with Five Drugs
Automated Average Bioequivalence Analysis with Additional Metrics and Statistics to Meet the FDA Guidance on Methylphenidate Hydrochloride Using Phoenix WinNonlin
Certara Scientists to Demonstrate Latest Modeling and Simulation Advances at AAPS PharmSci 360
PRINCETON, NJ – Nov. 1, 2018 – Certara today announced that its scientists will lead 15 sessions, and also host a Phoenix User Group Meeting, at the American Association of Pharmaceutical Scientists’ (AAPS) Annual Meeting – PharmSci 360.
Certara’s Dr. Craig Rayner Awarded 2018 Distinguished Alumni Award for the Faculty of Pharmacy and Pharmaceutical Sciences at Monash University
PRINCETON, NJ – Oct. 24, 2018 – Certara today announced that Craig Rayner, PharmD, MBA, senior vice president, integrated drug development with Certara Strategic Consulting, has been awarded the 2018 Distinguished Alumni Award for the Faculty of Pharmacy and Pharmaceutical Sciences at Monash University.
7 Things to Know About the China Pharmaceutical Industry
China is the second largest pharmaceutical market in the world. Demand is likely to increase as the government introduces reforms to improve the country’s health care system. These changes are helping multinational drug makers tap into the Chinese pharmaceutical market. Synchrogenix’s China Service Line has compiled a list of seven things to know about the … Continued
FDA Requirements for Providing Datasets for Nonclinical Studies in SEND Format
The CDISC Standard for the Exchange of Nonclinical Data (SEND) provides the structure and implementation rules for the submission of computer readable datasets. SEND is one of the required standards for data submission to the U.S. Food and Drug Administration (FDA) and specifies a way to collect and present nonclinical data in a consistent format. The … Continued
Certara’s Synchrogenix Division Collaborates with Hedera Hashgraph to Offer Data Flow and Transparent Collaboration Solutions for the Life Sciences Industry
2018年10月15日 – Certara today announced that it has formed a strategic collaboration with Hedera Hashgraph. Synchrogenix®, Certara’s regulatory sciences division, has been building distributed applications in the life sciences and healthcare markets that will expand its reach in the areas of transparency and disclosure, regulatory reporting and data sharing, and collaboration/communications from drug development through market access.
Application of In Silico PBPK Absorption Modeling to Justify Drug Product Dissolution Specifications—Analysis of Regulatory Submission Case Studies and Its Impact on Concept of Virtual BE
米国FDAがサターラのソフトウェアの使用を更新および拡張して新薬および生物製剤の審査を促進
PRINCETON, NJ – Oct. 9, 2018 – Certara today announced that the US Food and Drug Administration (FDA) has renewed, and in many cases increased, its number of Certara software licenses for reviewing new drug and biologics applications.