Time Dependent Pharmacokinetics of Pembrolizumab in Patients with Solid Tumor and Its Correlation with Best Overall Response
A selection of short essays from our blog containing insights from our thought leaders on how modeling and simulation has impacted and is continuing to reshape our approach to drug development.
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.
Population Pharmacokinetics and Exposure-response of Osimertinib in Patients with Non-small Cell Lung Cancer
In his most recent New York Times Magazine piece, “The Improvisational Oncologist,” Dr. Siddhartha Mukherjee, author of The Emperor of All Maladies: A Biography of Cancer, wrote, “In an era of rapidly proliferating, precisely targeted treatments, every cancer case has to be played by ear.” Oncology treatment: yesterday, today and tomorrow Mukherjee begins his article […]
Immuno-oncology, which harnesses the patient’s own immune system to fight cancer, is one of the hottest areas in drug development today. In recent years, the FDA has granted breakthrough therapy designations to multiple immuno-oncology drugs for a variety of oncology indications including advanced non-small cell lung cancer and melanoma. Over the last two decades, PK/PD […]
One of the biggest recent advances in cancer therapy has been the arrival of novel immunotherapies, such as anti-PD1 antibodies, which have demonstrated remarkable efficacy in multiple tumor types. In many instances supported by the ‘Breakthrough’ status granted by the FDA, many pharmaceutical companies are making huge efforts to bring these promising treatments to cancer […]