Innovative solutions to
keep your project on course

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?

Explore Our Blog

Former FDA Reviewers Provide Answers to Key Questions: Part 2

Two of Nuventra’s consultants, Gene Williams and Brian Furmanski, spent a combined 23 years working at the FDA. In Part…

Read More
What is Population PK

What is Population Pharmacokinetic (popPK) Analysis?

Population pharmacokinetics (popPK) is the study of variability in drug concentrations within a patient population receiving clinically relevant doses of a…

Read More

Lessons from FDA’s Grand Rounds: “How Simulation Can Transform Regulatory Pathways”

Modeling and simulation are transforming how drugs are developed and how they are regulated. This is the conclusion from a…

Read More