Method Development
Maxxam is experienced in bioanalytical method development and GLP method validation for pharmaceutical and biopharmaceutical products. Bioanalytical methods are validated in accordance with guidelines issued by the United States Food & Drug Administration (FDA) and the Organisation for Economic Co-operation and Development (OECD).
Our scientific team conducts method development for quantitation of parent drugs and their metabolites de novo or through method transfer and method optimization by LC-MS/MS. Parent drugs may be small molecules, peptides (up to 5000 Da) or proteins. Maxxam also maintains a portfolio of validated LC-MS/MS bioanalytical methods for specific drugs and their metabolites and offers LC-MS/MS method development and validation services for bioanalytical applications:
- Method Feasibility Assessment
- Method Transfer
- Method Development
- GLP Method Validation
- Cross Validation
- Methods for Drug-Drug Interaction Studies
- Metabolite Analysis and Identification
- Chiral Analysis
- Analysis of Multiple Analytes from Combination Drug Products
Standard parameters for method validation include:
- Analyte Accuracy and Precision
- Linearity and Range
- Specificity / Selectivity
- LOD / LOQ
- Standard and Sample Solution Stability
- Sample Stability in Matrix (including Freeze/thaw, Short term, Long term, and Room Temperature)
- Hemolysis (optional)
- Robustness (optional)
Click here for a list of our validated methods.
