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GLP Dose Solution Analysis

Dose Solution Sample Analysis Synchronized GLP & Dose-Solution Analysis (DSA) Studies

Same-day hERG and DSA results! We provide GLP and non-GLP analysis of dose solutions used in ChanTest concentration-response studies to verify the applied test article concentrations, plus the stability and homogeneity of the dose solutions. Stability testing is conducted in ChanTest’s buffers. The timing of the DSA study may be synchronized to begin with the hERG study so that solution stability may be optimized.

Benefits:

  • Our synchronized process minimizes compound-stability concerns
  • Determination of the test article dose solutions strengthens the accuracy and thoroughness of nonclinical cardiac safety studies, and is a requirement for GLP studies submitted in an IND dossier
DSA – Standard Assay Parameters
Non-GLP Method Development:
   Development of formulation solubility screen (nephelometry)
   Transferred analytical method assessment & initial validation
GLP Method Validation: (a)
   Chromatographic Non-Interference
   Linearity
   Accuracy & Repeatability
   Range
   Formulation Stability
   Stock Stability
GLP Dose Solution Analysis: (a,b)
   Concentration Verification
   Homogeneity of test article formulations
a Includes QC check of report and GLP QAU inspection of data, draft and final report
b Can be performed for non-GLP studies too (removing QAU audit)

Options:

  • Method development
  • Stock solution analysis