Modeling and simulation were used to optimize a sponsor’s Phase 3 clinical trial study design to achieve efficacy and safety goals as well as regulatory approval.
This blog asks and answers 10 critical drug development questions whether you have a new molecular entity or are repurposing a drug already in clinical use.
Henri Merdjan explains why topical drug formulations (e.g. intranasal and/or oral) could be valuable as a therapeutic option for COVID-19 patients.
Clinical pharmacology provides a valuable opportunity to accelerate the near-term development of existing repurposed drugs for COVID-19 treatment and therapy.
A quantitative modeling approach can be used to predict the optimal time to administer influenza vaccine during pregnancy to provide protection to infants at birth.
Innovative contracts are helpful in navigating an evolving pharma marketplace while providing new approaches to distributing life-saving treatments to patients.
This blog discusses how decision analysis approaches can help drug developers to better decisions under multiple criteria and uncertainty.
PBPK modeling using a virtual oncology population can help to predict exposure and accelerate the development of safe and efficacious oncology drugs.
A QSP model was built to evaluate its use in drug discovery for complex neurodegenerative diseases, e.g. Alzheimer’s.
A M&S model was built to offer an alternate approach to dedicated timing studies to determine the best time to vaccinate pregnant women.