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GLP Bioanalytical LC-MS/MS Services
Alta has conducted a wide variety of bioanalytical
studies in preclinical and clinical drug development. Alta specializes in
rapid methods development and validation and has the capability for rapid
sample analysis turnaround for all phases of drug discovery and
development including early pharmacokinetic, toxicology/toxicokinetic and
high volume clinical studies.
Sample Preparation Capabilities
- Sample control department designed to meet stringent
FDA Good Laboratory Practice Standards
- 96-well sample prep methodologies (liquid-liquid,
protein precipitation, and solid phase extraction
- OSHA compliant biohazard hoods and procedures for
handling of infectious samples
Method Development and Validation
- Non-GLP bridging studies
- Feasibility studies on new compounds done at no
charge with preliminary data available in 24-48 hours
- Development and validation < 4 weeks
- Start of assay to QC data - 3 - 5 days
- Start of assay of QA data - 1 - 2 weeks
- Response to aberrant data < 24 hours
Validated Methods
The following is a partial list of validated
methods routinely performed by the LCMS Services group. For further information please contact
Bob Bethem (VP of LCMS Services) or Dr. Jo Marie Smolec (Director of Business and
Development).
| Analyte |
Matrix |
Species |
Range (ng/mL) |
| Alfentanil |
Plasma |
Human |
1-1000 |
| Buspirone1-PP
Buspirone |
Plasma |
Human |
0.1-15,
.2-25 |
| Cyclosporin A |
Whole Blood/EDTA |
Human |
1-1000 |
| Methadone |
Plasma |
Human |
0.5-100 |
| Paclitaxel |
Plasma
/ NaHeparin |
Human |
0.05-10 |
| |
Plasma
/ NaHeparin |
Human |
1-500 |
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Whole
Blood / K3EDTA |
Human |
5-1000 |
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Plasma / NaHeparin |
Dog |
0.2-40 |
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