We Offer:

      Support for Model-Based Drug Development:

    • Population (nonlinear mixed-effects) PK and PK-PD data analyses, including preparation of FDA submission-ready reports;
    • Population pharmacokinetic and pharmacodynamic modeling and clinical trial simulation to support drug development programs;
    • Population PK-PD analysis of continuous or categorical responses, count data, survival, time-to-event, or QTc prolongation data;
    • Optimal design of pharmacokinetic and pharmacodynamic studies;
    • Pharmacokinetic and pharmacodynamic design and analysis of pediatric studies;

      Pharmacokinetic and Pharmacodynamic Analysis for Biologics:

    • Client support for model-based drug development of biologics;
    • Mechanistic population PK and PK-PD modeling of monoclonal antibodies and other biologics with target-mediated drug disposition;
    • Analysis of the preclinical data and scale up of preclinical models to humans for biologics with target-mediated drug disposition;
    • Design and analysis of first-in-man (FIH), Phase 1, Phase 2 and Phase 3 studies for drugs with target-mediated drug disposition (TMDD);

      Clinical Pharmacology Consulting:

    • General PK and PK-PD consulting;
    • Pharmacokinetic design of Phase 1 - Phase 3 study protocols;
    • Review of sponsor's protocols;
    • Due Diligence review of Clinical Pharmacology programs;

      In Vitro - In Vivo Correlation (IVIVC) Analysis:

    • Convolution-based In Vivo–In Vitro Correlation (IVIVC) Modeling;
    • Level-A Nonlinear mixed effects IVIVC modeling;

      On-demand Support of Sponsor's Modeling Efforts:

    • Data management support including preparation of the Nonmem-ready data files;
    • Expert guidance and technical support of Nonmem model development;
    • S-plus and R script development;
    • Expert support and critical review of population PK and PK-PD analyses;
    • Expert support and critical review of the sponsor's IVIVC analyses;
    • Preparation of publications;

      Training courses or workshops:

    • Mixed effects modeling using Nonmem: from data preparation to model evaluation (beginners to advanced level);
    • In-Vivo In-Vitro Correlation: theory, applications, and IVIVC model development;
    • Pharmacokinetic and pharmacodynamic modeling of biologics with Target-Mediated Drug Disposition;
    • R for pharmacometric data management and model diagnostics.

We guarantee fast turn-around time and complete transfer of know-how related to sponsor's projects. Strict confidentiality, scientific expertise and integrity, high efficiency and close collaboration with the sponsor form the foundation of our services.