Tag: 定量系统药理学
Certara Adds 4 Global Leaders to its Simcyp PBPK, QSP and QSTS M&S Division
New executives’ scientific, operational and consulting expertise will support Simcyp’s footprint in drug development and regulatory decision-making.
Managing Immunogenicity Using Quantitative Systems Pharmacology
The Challenge of Immunogenicity in Biologics Drug Development Biologic drug development is a rapidly evolving sector in the biopharmaceutical industry. Biologically-based therapeutic drugs comprise monoclonal antibodies (MAbs), vaccines, recombinant hormones and proteins, antibody-drug conjugates, RNAi, antisense, blood factors, and other large molecules. Although the success of biologics has been demonstrated, there are inherent operational and … Continued
Quantifying Age-related Brain Volume Changes to Support Neurodegenerative Disease Drug Development
Watch this webinar to learn why many major pharma organizations are investing in QSP for its potential to improve pharma R&D productivity.
Development of a Pre-clinical Quantitative Systems Pharmacology Model for E7046, a Novel PGE2 Receptor Type 4 Antagonist for Cancer Immunotherapy
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.
Model Firsts
By combining disparate data into coherent mechanistic models, quantitative systems pharmacology is becoming a key tool for picking the right dose for first-in-human trials and other early make-or-break decisions.
Certara Experts Highlight Quantitative Systems Pharmacology’s Role in First-in-human Clinical Trials
PRINCETON, NJ – 2018 年 7 月 26 日 – Certara announced today that Clinical Pharmacology & Therapeutics has published its “Letter to the Editor” describing the important role that quantitative systems pharmacology can play in defining dosing criteria for first-in-human clinical trials, together with the European Medicines Agency’s response.
Certara’s Best of the Blog 2017
A selection of short essays from our blog, written to empower our customers with modeling and simulation (M&S) and regulatory writing solutions in order to help them solve the toughest drug development problems. Certara staff contributions range in topic from pharmacometrics to systems biology to the growing importance of regulatory writing and sharing clinical trial results.
Certara Launches Industry-first Quantitative Systems Pharmacology (QSP) Consortium on Immuno-oncology with Leading Pharma Company Members
PRINCETON, NJ – Mar. 13, 2018 – Certara today announced the launch of its Quantitative Systems Pharmacology (QSP) Immuno-oncology Simulator Consortium.
