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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, at physiological temperature for GLP studies. 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 |
GLP
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Non-GLP
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| Development of formulation solubility screen (nephelometry) |
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Optional
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| Transferred analytical method assessment & initial validation |
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| Quality control sample testing |
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| Stability testing of test article formulations |
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| Samples tested: |
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| # per concentration |
1
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1
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| # per stock solution (in DMSO) |
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1
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| # homogeneity of test article formulations (3 positions per concentration solution) |
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| QC audit of draft report |
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| QAU GLP audit of draft and final reports |
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Options:
- Method development
- Stock solution analysis
 CRB-DSA assay bulletin.pdf
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