Nonclinical Dose Formulation and Analysis

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Nonclinical Dose Formulation and Analysis 2017-07-04T10:25:16+00:00

Dose Formulation and Analysis

The pharmacokinetic and pharmacodynamic impact of formulation design requires accurate analysis and consistent, validated production of test compound formulations. MPI Research responds to the challenge with

  • Extensive experience in formulating nonclinical dose formulations in a wide variety of vehicles including suspensions, oils, and diet admixtures
  • Unrivaled expertise in method development and validation via a structured, systematic approach
  • Highly specific and sensitive techniques

Nonclinical Formulation and Analysis Needs

MPI Research provides comprehensive nonclinical dose formulation analysis, including stability, homogeneity, potency testing, and solubility assessment to support GLP safety studies. The methodologies we develop using our highly structured and systematic approach are robust and fully transferable between laboratories. As the leaders in our field, we have authored industry-leading white paper guidance for the validation and analysis of formulated test articles. MPI Research can assist in the design of robust formulations for preclinical use. Our analytical and formulation groups operate at the same site, allowing rapid and seamless method transfer and qualification.

Service Highlights

  • Diverse analytical platforms including Waters Alliance, Acquity and Agilent 1200 Liquid
  • Chromatography (LC) systems with photodiode array, fluorescence, and mass spectrometric (MS and MS/MS) detection
  • Various platforms to analyze proteins and peptides including
    • HPLC (reversed phase, SEC, and affinity)
    • Total protein assays (ultra-violet
      [UV] spectrophotometric and colorimetric assays)
  • Experience with various vehicle types including solutions, suspensions, creams, oils, and dietary ad-mixtures
  • Flexible scheduling with excess capacity to accommodate last-minute requests, changes in timelines, and rapid study starts
  • Systematic approach to method development and validation that results in analytical methods being available for routine analysis of formulated materials before dosing
  • Start-to-finish collaboration with our colleagues in drug safety, as we execute all aspects of general toxicology, safety pharmacology, and development and reproductive toxicology