A Quantitative Systems Pharmacology (QSP) approach for developing combination immune-oncology therapies can be used to better predict effective drug combinations, especially to more accurately correlate the physiological differences between preclinical models and human patients.
Certara’s Simcyp PBPK M&S Technology Achieves First FDA Virtual Bioequivalence Approval for ‘Complex’ Generic Drug
PRINCETON, NJ – June 12, 2019 – Certara’s Simcyp®️ physiologically-based pharmacokinetic (PBPK) modeling and simulation technology was used to demonstrate bioequivalence (BE) for the US Food and Drug Administration (FDA) approval of a complex generic drug on the agency’s abbreviated new drug application (ANDA) pathway.
Certara Scientists to Highlight Model-informed Drug Development, PBPK, MBMA and QSP Progress at PAGE 2019
Certara is contributing to 28 sessions, showcasing modeling by its pharmacometricians, systems pharmacologists, and experts in pharmacoeconomics/health economics outcomes research
Read this blog profiling the student scholarship winners for the 28th annual meeting for the Population Approach Group in Europe (PAGE).
June 27, 2019 – This webinar will explain how the Simcyp Animal Simulators support developing safer and more effective human and veterinary medications.
Pirana is a flexible and extendible modeling workbench with an intuitive graphical user interface for facilitating pharmacometric workflows for NONMEM, PsN, Xpose/R, and more. Pirana’s research tools facilitate the iterative processes used to create Pop PK/PD models, resulting in better organization and more efficient analysis of results.
It is a multi-functional, cloud-based, 21 CFR Part 11 compliant platform for clinical pharmacology, pharmacometrics and clinical operations professionals.
Maximize your understanding of your anti-cancer drug’s safety and efficacy profile to achieve regulatory and commercial success with Certara’s strategic and technology-enabled services across the entire drug development continuum – from pre-clinical first-in-human studies to regulatory submissions, health economics/outcomes research and market access value communication.