ALTA Analytical Laboratories

Alta Analytical Laboratory
1100 Windfield Way
El Dorado Hills, CA 95762
Lab: (916) 933-1640
Fax: (916) 933-0940

Services
Non-GLP Discovery Support

ALTA provides rapid turnaround non-GLP bioanalysis in support of discovery and early drug development studies with a dedicated discovery project team. Typical time for delivery of data after sample receipt is 5 days or less provided that a 1-week advance notice is given. Three modes of analysis can be provided based on your data requirements.

Mode I  - Rapid Discovery Screen

·         Optimize instrument, run curve and samples directly using a generic method without prior assessment.

Mode II – Lead Optimization (non-GLP Early Pharmacokinetic Studies)

·         Set up and run an extracted curve (protein ppt or other extraction method as needed) and QC spikes to evaluate method performance and range (Day 1).

·         Assay Samples with freshly prepared curve (N=2 at each concentration) and QC spikes (Day 2)

Mode III – Lead Qualification (Bridging and non-GLP Toxicokinetic Studies)

This experimental design will include:

·         Intra-assay precision and accuracy QCs (N=5 at low, mid and high)

·         Lower Limit of quantitation (LLOQ) (N=5)

·         Room temperature matrix stability (N=3)

·         Room temperature extract stability (re-injection of curve and QCs)

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