Pharmacometrics Regulatory Strategy

Predictive Disease-Drug-Trial Modeling and Simulation

A well-designed pharmacometrics regulatory strategy satisfies multiple goals. First, the strategy prioritizes the needs of the program and details when and how they will be met. Next, a strategic road map provides direction that ensures that studies and analyses will be fit-for-purpose and add value to the program. Finally, a robust strategy facilitates positive interactions with regulators, commercial partners, and payers.

For more than 15 years, our scientists have combined insight and innovation to build quantitative models of the interactions between the human body, drug effects, and diseases. Our team of more than 100 pharmacometric scientists provide quantitative solutions to key issues that clients face throughout the clinical development process, including:

Phase of Development/Our Typical Services


  • Support first-in-human (FIH) designs by bridging pre-clinial PK/PD data and predecessor compounds
  • Translation from animal to human data for safety and efficacy
  • Assess cardiac safety risk
  • Identify exposure-safety, exposure-PD, and exposure-activity relationships
  • Establish early view on drug-drug interactions (DDI) using PBPK models
  • Determine FIH dose justification rationale

Phase 1 through Proof-of-Concept

  • Clinical Pharmacology Quantitative PK/PD Evaluation
  • Support PoC designs by modeling the time-course of disease, the compound effect, and the effect of patient variables. Evaluate PoC success criteria.
  • Support strategies to evaluate Proof of Mechanism
  • Support conduct of clinical pharmacology programs through Quantitative Pharmacology services (Data management, Non-compartmental analysis, Clinical study report contributions)
  • Drug metabolism consultancy (eg, to optimize drug-drug and drug-food interaction strategy)

Proof-of-concept through pre-NDA activities

  • Support dose and regimen selection trials by bridging Phase 1 PK/PD data and predecessor compounds
  • Support expansion into new indications by bridging across indication
  • Define the efficacy and/or safety margin vs. comparators by performing a comprehensive safety/efficacy evaluation utilizing literature data
  • Develop and implement strategic modeling and simulation plans that are integrated into the Clinical Development Plan
  • Develop criteria for interim analysis – evaluate innovative designs
  • Assess drug-drug interactions and other safety concerns
  • Optimize alternative drug formulations
  • Comparison to competitor compounds – comparative effectiveness
  • Population PK and exposure-response design
  • Support regulatory interactions

Registration activities

  • Dose justification
  • Population PK analysis
  • Exposure-response analysis
  • Support response to regulatory questions
  • Author clinical pharmacology and pharmacometric components of registration files


  • Comprehensive safety/efficacy evaluation including comparison of double-blind and open-label trials
  • Support publication strategy


  • Special populations – support pediatric and orphan drug trial designs
  • Special populations – hepatic and renal impairment, co-morbidities
  • Special populations – PK/PD bridging to Asian and other ethnic populations
  • OTC, generics
  • Global health
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