Quantitative Pharmacology and Pharmacometrics

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PKPD.pngExposure (and Dose) Response Analyses, including pharmacokinetic and pharmacodynamics analyses, guide critical decisions in drug development. Cytel’s expert Quantitative Pharmacology and Pharmacometrics group delivers high quality solutions to help our customers get those decisions right.

Phase I Biometric Services Including Pharmacokinetic (PK) Analyses

  • Non Compartmental Analysis (NCA)
  • PK Tables Listings and Figures
  • PK section of Clinical Study Report
  • SAS.XPT (transport) Files
  • ICH Listings
  • Trial Design

Statistical analysis and reporting for first in human studies:

  • Single Ascending Dose (SAD) Studies
  • Multiple Ascending Dose (MAD) Studies
  • SAD/ MAD studies
  • Drug-Drug Interaction Studies
  • Food effect- drug/ food interaction studies
  • Bioavailability and Bioequivalence Studies

Pharmacometrics analyses

  • Population PK modeling including identifying significant covariates of exposure
  • Exposure-response population modeling and simulation of safety/ and or efficacy endpoints
  • Nonlinear modeling of biomarker to clinical endpoint relationships
  • Model-based meta-analysis
  • Risk-benefit assessments and identification of therapeutic index

Clinical Database Development

  • Source Database (SDB)
  • Outcomes Database (ODB)
  • Comparator Database:
    Using a refined process and proprietary software PubCode , we can efficiently extract summary level clinical trial outcome data along with detailed information on treatment, patient population, and trial characteristics.

Cecilia Fosser

Cecilia Fosser, PhD, is a Lead Pharmacometrician. She designs advanced approaches for quantitative drug development by combining statistical and pharmacometrics techniques.

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Cecilia Fosser is Director, Quantitative Pharmacology and Pharmacometrics, at Cytel. She combines statistical and pharmacometrics techniques to develop advanced approaches for quantitative drug development. Her experience includes Phases 1–4 of clinical trial development and spans a range of therapeutic areas. In the past, she has worked with Pfizer’s Pharmacometrics Group, with a focus on inflammation.


Her publications include work on exposure-response analyses of multiple endpoints. She has delivered presentations at several large international conferences such as ASCPT and ACoP. Cecilia obtained a PhD in Applied Mathematics from the University of Arizona.