Tag: Oncology/Hematology
Development of a Population Pharmacokinetic Model for Binimetinib with Subsequent Exposure-response Analyses in NRAS Mutant Melanoma
A Product-profile-driven Clinical Utility Index (CUI) Analysis to Balance Benefits and Risks for Dose Selection in Oncology
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.
Precision Dosing in Clinical Medicine: Present and Future
Pharmacodynamic Analysis of Eribulin Safety in Breast Cancer Patients Using Real-world Postmarketing Surveillance Data
Population Pharmacokinetics of Vancomycin in Patients Undergoing Allogeneic Hematopoietic Stem-cell Transplantation
Using M&S to Evaluate Oncology Drug Dosing
There are numerous challenges in developing oncology drugs: (1) they are often very toxic which precludes conducting clinical trials in healthy volunteers, (2) the PK of a drug may be altered in cancer patients due to demographic and physiological differences as compared to healthy volunteers, and (3) cancer patients face elevated drug-drug interaction (DDI) risk … Continued
Translational PBPK Modeling of IDH305, an Inhibitor and Inducer of CYP3A4
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.
