We Offer:
  • Population (nonlinear mixed-effects) pharmacokinetic (PK) and pharmacodynamic (PK-PD) modeling and clinical trial simulation to support drug development programs;
  • Population PK and PK-PD data analyses, including preparation of FDA submission-ready reports;
  • Client support for model-based drug development of biologics and small molecule compounds;
  • Mechanistic population PK and PK-PD analysis of monoclonal antibodies and other biologics with target-mediated drug disposition;
  • Analysis of the preclinical data and scale up of the preclinical models to human for biologics with target-mediated drug disposition;
  • Design and analysis of fist-in-man, Phase 1, Phase 2 and Phase 3 studies for drugs described by the target-mediated drug disposition (TMDD) equations;
  • Clinical pharmacology consulting;
  • Pharmacokinetic design and analysis of pediatric studies;
  • Population PK-PD analysis of continuous or categorical responses, count data, survival, time-to-event, or QTc prolongation data;
  • General PK and PK-PD consulting;
  • In vivo - in vitro correlation (IVIVC) analysis;
  • On-demand support of sponsor's modeling efforts, including data management, NONMEM 7, S-plus and R script development;
  • Critical review of population PK and PK-PD analyses;
  • Presentation at conferences and meetings;
  • Preparation of publications;
  • Fast turn-around time and complete transfer of know-how related to the sponsor's projects.
Strict confidentiality, scientific expertise and integrity, high efficiency and close collaboration with the sponsor form the foundation of our services.