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Method Review

A bioanalyical method validation program for laboratories performing pharmacology assays

About CPQA’s Assay Peer Review Program

CPQA’s blinded peer review program assures the quality and acceptability of the bioanalytical methods used by a clinical pharmacology laboratories (CPL). A laboratory’s assay validation report (AVR) and subsequent method standard operating procedure (SOP) methods are reviewed according to CPQA’s Guidelines for Chromatographic Method Development and Validation . Using these guidelines assures that methods are reviewed using a consistent set of standards.

The method review process is blinded—reviewers do not know which laboratory’s documents they are reviewing and laboratories do not know the names of reviewers. This helps eliminate bias and potential conflicts of interest. Reviewers are hand-selected by CPQA based on their knowledge, expertise, and experience in pharmacology assay method development.

The method peer review program has performed reviews from laboratories across the world. The peer review program was implemented using a custom-built web application specifically designed for method reviews. Method submission and review are handled through the secure application, which allows CPLs to submit method documents and follow the submission throughout the review process. Reviewers also use the web application to complete reviews and provide the CPLs with comments and a score.

Peer Review Process

  1. Submit

    • CPL submits through online utility
    • CPL receives email verification of submission
  2. Assign

    • CPQA receives email notification and assigns to reviewer using the online utility
    • Reviewer confirms assignment using the online utility
    • CPL receives email notification that submission is in review
  3. Score

    • Reviewer completes review using online utility, and assigns on of the following scores:
    Accept
    • CPL receives email notification that the review has been completed, the method accepted and no revisions needed

    OR

    Revise
    • The CPL receives email notification that the review has been completed, the method tentatively accepted but requires minor revisions
      OR
      The CPL receives email notification that the review has been completed, the method has not been accepted and requires major revision
    • In both cases, the CPL will need to re-submit

Drug Assay Directory

CPQA compiles details for samples, analysis, and performance of all CPQA-approved methods in a monthly spreadsheet called the CPQA Drug Assay Directory. The Drug Assay Directory can be used by network leadership, protocol teams, committees, and support staff to determine what drug testing and methods are available at participating laboratories.

View Drug Assay Directory