Tag: Oncology/Hematology
Mechanistic quantitative pharmacology strategies for the early clinical development of bispecific antibodies in oncology
Bispecific antibodies (bsAbs) have become an integral component of the therapeutic research strategy to treat cancer. In addition to clinically validated immune cell re‐targeting, bsAbs are being designed for tumor targeting and as dual immune modulators. Explorative preclinical and emerging clinical data indicate potential for enhanced efficacy and reduced systemic toxicity. However, bsAbs are a … Continued
Optimizing the Regulatory Strategy for an Anti-cancer Drug
Certara scientists performed helped a small biotech company create a clinical pharmacology package for their NDA submission for a novel oncology drug.
Certara’s Best of the Blog 2019
A selection of short essays from our blog, written to empower our clients with modeling and simulation (M&S), regulatory science, and real-world value assessment solutions to help them solve the toughest drug development problems. In the Best of the Blog, Certara’s scientists and regulatory experts share their learnings, technological advances, and thought leadership.
Simcyp: 20 Years of Innovation
The consortium members have partnered with Simcyp and Certara during the past 20 years to advance the science of drug development through modeling & simulation
Mechanisms of Physiological Changes in Drug Exposure in Cancer Patients
This webinar discussed how to use a PBPK cancer population to investigate tumor disposition and therefore, impact on treatment regimens.
Development of Paclitaxel PBPK Model to Predict Tumour Concentration in Cancer Patients
Mechanistic models of cancer Mechanistic models cancer-immune cycle and immunotherapies
Integration of a Tumour Growth Inhibition Model within a Mouse Physiologically-Based Pharmacokinetic Model
Optimize Immuno-oncology Drug Discovery and Development Using QSP
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.