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 |
b Can be performed for non-GLP studies too (removing QAU audit)
Options:
- Method development
- Stock solution analysis