Quantitative Pharmacology and Pharmacometrics

Source: Cytel
Quantitative Pharmacology and Pharmacometrics

Exposure (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.

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