Comparator PK/PD Analysis
Pre-Market and Post Approval Guidance | How will your drug stand out in the marketplace?
Throughout the drug development process (pre-market), and as you introduce your new drug to the marketplace (post-approval), a Comparator PK/PD Analysis can help guide your next steps and frame your messaging. With modeling, simulation and a meta-analysis of clinical data, our team of industry-veteran pharmacometricians can conduct a Comparator PK/PD analysis and evaluate a drug’s:
- Efficacy,
- Safety,
- Toxicity
- and more
Pre-Market Guidance
Robust sales of approved pharmaceuticals start with intelligent pre-market drug development strategies. PK/PD analyses can help position your drug to:
- Optimize dosing,
- Reduce time to market,
- Strengthen market position versus competitors,
- Enhance uptake by the medical community
- and more
Post-Approval Guidance
By the time a drug gets to market, the pressure is on to sell. Imagine being able to hand a physician an evidence-based analysis showing how your drug is better for their patients than your competitor’s drug? Comparator PK/PD Analyses can provide the information you need to be able to do just that.
Investigator-Initiated Studies
Data for your drug is being generated and published from Investigator-Initiated Studies. Our team works with Investigators to ensure that:
- Studies are designed appropriately to produce robust results
- Studies are conducted according to all FDA regulations
Questions a Comparator PK/PD Analysis Can Answer
- What is the optimal dose for patients?
- How does your drug’s efficacy compare with competitors?
- How can your drug be used with other medications?
- How should you position your drug in the marketplace?
- How does your drug’s safety compare with competitors?
