DMPK Services

Brief  Overview

DMPK services include the planning of necessary studies for regulatory filing at the appropriate time and mechanistic studies when required’

       Pharmacokinetics

      Single and Multiple Dose, Dose Proportionality, Absolute Bioavailability, PK/TK Modeling

      Mass Balance/Excretion/Radiolabel Studies

      Formulation Optimization, Intestinal Permeability, other Mechanistic studies

      Bioequivalence analysis

      PK and PK/ PD analysis

      In Vitro - In Vivo Correlation (with Pharsight™ IVIVC toolkit software)

      WinNonlin™ for PK analysis and SAS for statistical analysis

       Protein Binding; RBC/Plasma Distribution Partitioning

      Protein Covalent Binding

       Tissue Distribution

      Discovery QWBA

      Quantitative Whole-Body Autoradiography (QWBA)

      Micro-autoradiography (MARG)

       Metabolism

      Metabolic Stability, Species Comparison, CYP450 Inhibition/Induction

      Metabolic Reaction Pathway Profiling

 

      Metabolite Profiling & Identification – In Vitro, Preclinical, and Clinical