The European Medicines Agency (EMA) recently approved dulaglutide (Trulicity®) at higher doses (3 mg and 4 mg solutions). Dulaglutide is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise. Dulaglutide delays gastric emptying and has the potential to impact the rate of absorption of … Continued
Tag: Model-informed Drug Development
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.
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.
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.
Modeling and simulation can help veterinarians provide better care for animals and guide research study design thereby maximizing the knowledge gained from research studies whilst minimizing the number of animals used. In this webinar, we looked at how PBPK modeling can be used to predict the absorption, distribution, metabolism, and excretion of drugs in humans and other animal species.
PRINCETON, NJ – February 7, 2019 – Certara has recently published four peer-reviewed MIPD papers; its progress is generating strong interest from industry, health care professionals and regulators.
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.
The impact of MIDD is especially powerful in oncology, where numerous cases demonstrate its enormous value in streamlining and accelerating the development cycle and supporting breakthrough therapy options for these fragile patients.
PRINCETON, NJ – Apr. 5, 2018 – Certara and faculty at the UNC Eshelman School of Pharmacy today announced the winners of the first Model-informed Drug Development (MIDD) Gran Prix. The event finals were held on March 24 at the 2018 American Society for Clinical Pharmacology & Therapeutics (ASCPT) Annual Meeting.
A look at how to leverage modeling and simulation technology to enhance all phases of the drug development process.