This series of blog posts describes some of the benefits of partnering with Nuventra to meet your PK/PD needs in drug development.
Improving Decision-Making for Clinical Development Programs with Dose Selection
- Companies invest millions of dollars conducting research to identify a dose that is safe and efficacious.
- Pharmacokinetics and population PK/PD are crucial to predicting the safety and efficacy of potential dosing regimens during drug development, as well as justifying dose selection for registration.
- Applying clinical pharmacology and PK/PD techniques throughout drug development is similar to building a story about the PK/PD characteristics of your drug. Nuventra’s team of senior-level pharmacokineticists and clinical pharmacologists has the knowledge to build your story, and selecting your dose, intelligently.
Take home message:
Save time and money by incorporating robust pharmacokinetic techniques for modeling and simulation as early in the drug development process as possible (model-based drug development). Clients engaging Nuventra during IND-enabling studies typically gain important insights into the behavior of their drug, allowing for more informed choices for clinical dose levels. Clients engaging Nuventra during early phase clinical studies may also improve decision making ability in designing late stage efficacy trials.
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