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)


