The Certara Blog

Author: Nastya Kassir

Dr. Kassir joined Certara in 2008. She earned a PharmD at the Lebanese University and a doctorate in pharmaceutical sciences at the University of Montreal. Her doctoral research focused on population PK/PD modeling in pediatric transplant patients. At Certara, she is responsible for the analysis of PK/PD data from preclinical and clinical studies and for writing clinical study reports. In addition, Dr. Kassir performs PK/PD and statistical analyses according to state-of-the-art methods and regulatory requirements. She also interprets results and writes clinical study reports. Her expertise is in non-compartmental and compartmental analysis to investigate dose response and population PK/PD relationships to support drug development. She has contributed to numerous drug development decisions and regulatory filings where questions from regulatory authorities (EMEA, FDA, PDMA) were addressed using population PK /PD modeling and simulation. Dr. Kassir has experience in various therapeutic areas and special populations: pediatrics, rare diseases (atypical hemolytic-uremic syndrome, paroxysmal nocturnal hemoglobinuria), Inflammatory diseases (rheumatoid arthritis, psoriasis, Familial Mediterranean Fever), and CNS. To date, Dr. Kassir has authored or co-authored more than 20 manuscripts and scientific communications related to drug development.

Recent Posts

The Anatomy of a Great Biosimulation Project

In therapeutic areas with tough competition, it is challenging to establish a complete, confident understanding of a drug’s safety and efficacy profile. Any misunderstanding of a drug’s characteristics can derail the entire development program. Biosimulation, also known as model-based drug development, uses a number of techniques, such as population PK modeling, model-based meta-analysis, and PBPK […]

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Pediatric Drug Dosing: Tackling Big Problems for Little Patients

The challenges and complexities of pediatric drug development are well recognized. Pharmacometric modeling and simulation (M&S) leverages prior knowledge to support pediatric drug dosing, trial design and regulatory writing for submissions. As the benefits of pharmacometrics for drug development and regulatory decision-making become increasingly well documented, the FDA has challenged the industry to more rigorously apply […]

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