Year: 2018
Modeling Double Peak Phenomenon and In Vitro-In Vivo Correlation (IVIVC) in Pharmacokinetics (PK) for Clinical Trial Simulation (CTS) of Virtual Bioequivalence (BE) Studies
Development of a Population Pharmacokinetic Model for Binimetinib with Subsequent Exposure-response Analyses in NRAS Mutant Melanoma
A Product-profile-driven Clinical Utility Index (CUI) Analysis to Balance Benefits and Risks for Dose Selection in Oncology
Certara to Participate in 40 Pharmacometrics Modeling and Simulation Sessions at ACoP9
PRINCETON, NJ – Oct. 5, 2018 – Certara today announced that it is participating in 40 sessions at the ninth American Conference on Pharmacometrics (ACoP9).
Immunogenicity Prediction and Dose Optimization using Clinically-Validated In Silico Modeling and Simulation
Biologic drug development is a rapidly evolving sector in the biopharmaceutical industry. Immunogenicity is an inherent challenge with this complex class of drugs. A quantitative systems pharmacology approach can be used to predict and better manage immunogenicity, and as a tool to guide clinical and regulatory decision-making in biologics drug development.
FDA’s New ANDA Submissions Guidance: Key Points
The U.S. Food and Drug Administration (FDA) published notice of a new ANDA submissions guidance on September 24. The final guidance for industry titled, “ANDA Submissions – Content and Format” is intended to assist applicants in preparing complete and fileable abbreviated new drug applications (ANDAs) for submission to FDA. The primary purpose of this guidance is to … Continued
Certara Trial Simulator 版本 2.3：强大、灵活和直观
Anticipate risks and preview the range of expected results before millions in R&D dollars are spent and human subjects are exposed to experimental therapies.
Certara Launches BaseCase® Portal™, Enabling Life Sciences Companies to Deliver Therapeutic Decision-making Apps to HCPs at the Point of Care
PRINCETON, NJ – Sept. 26, 2018 – Certara announced today the launch of its BaseCase Portal cloud-based platform, that allows for the rapid creation of fully-customizable mobile apps that connect live to mathematical models and algorithms, and help HCPs optimize treatment for individual patients.
How to Use a Reference-scaled Average Bioequivalence Approach for Narrow Therapeutic Index Drugs
Watch this webinar to learn how RSABE for NTIDs can be performed in Phoenix WinNonlin using a reusable template.
