eagle-i The Ohio State UniversityThe Ohio State University

Analytical Method Development and Validation for Quantitative Assays

eagle-i ID


Resource Type

  1. Data analysis service


  1. Fee for service
  2. Resource Description
    The PhASR staff offers expertise in developing and validating quantitative assays optimally suited for small molecules and peptides (LC-MS/MS), protein therapeutics (ELISA) and oligonucleotide therapeutics (ELISA and qRT-PCR). Proper analytical method development ensures appropriate understanding of factors that could influence results obtained with bioanalytical measurements or with measures of drug activity. For example, lack of understanding about compound solubility and stability may lead to incorrect conclusions from in vitro or in vivo pharmacokinetic or pharmacodynamic studies. Full validation of a newly developed method, based on the Guidance for Industry, Bioanalytical Method Validation published by the U.S. Food and Drug Administration, is completed for all work involving clinical trials, and it is recommended for all methods producing results intended for publication in non-clinical studies. Accurate and sensitive quantification of drugs, metabolites and endogenous biomolecules requires developing and validating analytical methods optimized for precision and accuracy. For LC-MS methods, this involves appropriate selection of internal standards, solvents or solid-phase media for efficient sample extraction, LC mobile phases, analytical columns, liquid flow rates, gradients, ion polarity, daughter ions, gas flow rates and other general MS parameters. For some compounds, LC-MS may not be the most appropriate method of quantitation and an alternative detection method should be considered. The outcome of the Analytical Method Development and Validation service is a validated method for accurate and precise quantitation of a specific compound within a given matrix (e.g. blood, plasma, tissue, urine, etc.).
  3. Contact
    The Pharmacoanalytical Shared Resource
  4. Service Provided by
    The Pharmacoanalytical Shared Resource
  5. Website(s)
  6. Part of Collection
    The Ohio State University Comprehensive Cancer Center Collection
Provenance Metadata About This Resource Record

    Copyright © 2016 by the President and Fellows of Harvard College
    The eagle-i Consortium is supported by NIH Grant #5U24RR029825-02 / Copyright 2016