While a PMx model can be valuable, successful drug development and commercialization hinge on making the right critical development and regulatory decisions. This can be achieved by simulating the model to address key questions such as:
- Dose-Response Relationship: What is the relationship between dose and pharmacological response?
- Efficacy and Safety: How does the drug perform in terms of efficacy and safety across different populations?
- Drug-Drug Interactions: How does the drug interact with other medications? What are the implications for combined therapies?
- Special Populations: What is the impact of specific populations (e.g., pediatric, geriatric, pregnant) on drug pharmacokinetics and dynamics?
- Exposure-Response Analysis: How does exposure to the drug relate to therapeutic and adverse effects?
- Optimal Dosing Regimens: What are the most effective and safe dosing regimens based on model simulations?
I can conduct (clinical trial) simulations to help you find answers to these essential questions within the drug development program. For instance, if a Phase I clinical trial has been run for an infectious disease, it may be necessary to assess potential safety issues associated with administering a higher dose. I can provide insights into this and other inquiries, no matter the program’s therapeutic area.
Moreover, to enable prompt simulation results , I can build easy-to-use R-shiny apps. This can be particularly useful in early the early phases of drug development and/or pre-clinical phase when many parameters may simultaneously impact model predictions.