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.
- 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
Reasons to Conduct DSA at ChanTest:
- Stability of dosing formulations in hERG buffer can be problematic:
- Our published data: 20% of test articles are not stable in hERG buffer for 24 hours at room temperature or frozen conditions.
- In these instances, samples cannot be collected and shipped to an outside analytical lab. ChanTest performs dose verification the same day as the hERG assay to alleviate these issues.
- With same day dose verification, the required stability analyses needed for GLP compliance is reduced to 24 hours (this is typically 8 days for an outside analytical laboratory). Thus the number of experimental days is decreased which leads to a faster turnaround time.
- There is only one “queue” to get into. When dealing with ChanTest for the hERG assay and an outside laboratory for the analytical work, the client needs to get into both places’ queues (actual experimental queue as well as Quality Assurance Unit queue).
- When both portions are performed at ChanTest, we promise an audited integrated, draft report within 6 weeks of the study start date (from start of analytical method development). When dose verification is performed at an outside laboratory, the first audited draft from ChanTest does not contain the analytical data since we have not received the outside analytical draft report at that point.
- GLP hERG with outside DSA takes on average 87% longer between the time a draft report is sent to the time a final report is signed.
|DSA – Standard Assay Parameters|
|Non-GLP Method Development:|
|Development of formulation solubility screen (nephelometry)|
|Transferred analytical method assessment & initial validation|
|GLP Method Validation: (a)|
|Accuracy & Repeatability|
|GLP Dose Solution Analysis: (a,b)|
|Homogeneity of test article formulations|
- Method development
- Stock solution analysis