Computer simulation provides an effective means for evaluating whether a clinical trial design is efficient and optimally informative with a high likelihood of success. Many variables affect the likelihood of success of a trial, and genetic variation in the population is being evaluated with increasing frequency for its impact on trial outcomes.
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.
PRINCETON, NJ – 2018 年 6 月 14 日 – Certara was privileged to participate as a key member of the Medicines Development for Global Health development team to achieve FDA approval of moxidectin.
Infants face a gap in protection against influenza between birth and the time of vaccination. Thus, maternal immunization is the only way to prevent flu infection in pregnant women and newborns. Our current understanding of the optimal timing of vaccination is rudimentary. Watch this webinar with Dr. Michael Dodds to learn how modeling and simulation (M&S) offers an alternate approach to dedicated clinical studies to determine the best time to vaccine pregnant women against influenza.
