Bioanalysis, Preclinical and Clinical
We provide bioanalytical methods development, validation and sample analysis in our FDA-GLP registered facility in Bristol, CT.
We support all types of preclinical studies from early discovery (ADME, PK, TK) through long-term chronic in all species. Pinelake bioanalysis group has many years of methods development experience in complex matrices such as brain, spleen, spinal cord and vaginal tissue, in addition to the traditional matrices of blood, plasma and urine.
Sample data is processed and reported using Watson LIMS software. All reports are delivered as “ready to file” documents. We also offer full API characterization as well as formulation concentration and stability analysis.
Preclinical and Clinical Bioanalysis
- Method development and validation
- Plasma, blood, serum, synovial fluid, urine and feces
- Tissues: Liver, kidney, spleen, brain, spinal cord, heart, eye, muscle, dermis
- Species: Non-human primate, rodent, canine, porcine, bovine and human
- Validation according to FDA guidance
- Small and large molecules, oligonucleotides and aptamers
- Liquid-liquid extraction, solid phase extraction, protein precipitation, digestion
- UPLC-MS/MS, Waters UNIFI software
- Watson LIMS