Nonclinical Safety Testing & Discovery Services
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DOSE SOLUTION SAMPLE ANALYSIS

 

Analyze test article solutions applied to test systems to verify concentrations
ChanTest’s Analytical Services Department provides GLP and non-GLP testing and analysis of dose solutions used in ChanTest concentration-response studies to verify the applied test article concentration, stability and homogeneity. 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
Parameters
GLP
Non GLP
Method Transfer Validation
x
x
Stability Testing of Test Article Formulations
x
  
Samples Tested:    
    # per concentration
1
1
# stock solution (in DMSO)
1
1
# homogeneity of test article formulations
(3 positions/conc.)
x
x
QC Audit of Draft Report
x
x
QAU GLP Audit of Draft and Final Reports
x
  
 

Options:

  • METHOD DEVELOPMENT – Available upon request
  • STOCK SOLUTION ANALYSIS– Available upon request
  • SOLUBILITY ANALYSIS – Determine solubility with nephelometry-based solution testing