Bioanalytical

Our Advanced Mass Spectrometry Laboratory offers state-of-the-art LC-MS/MS to rapidly and reliably identify and analyze compounds. Using your validated method or one that we develop for you, we analyze bioanalytical samples in compliance with the FDA's GLP requirements and the current ICH guidelines. The highly selective nature of LC-MS/MS reduces the need for confirmatory testing and provides the top quality data you need to select and develop your drug candidates.

Applications

Lead Selection - Early ADME

• In vitro metabolism screening
• Rapid turnaround pharmacokinetic studies
• Cassette dosing PK

Drug Development - IND to NDA

• Method development/method validation
• Bioanalytical sample analysis
  - Tox and ADME samples
  - Phase I-III clinical samples
• Confirmatory testing
• Compound identification
  - Drug substances
• Small organic molecules
• Metal complexes
• Peptides
• Oligonucleotides
  - Metabolite/degradate/impurity
• Biomatrices