Comparator PK/PD Analysis – Pre-Market and Post-Approval Guidance

Comparator PK/PD Analysis

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 GuidanceComparator PK/PD Analysis

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?