Pharmacokinetics

Small molecules 

Most drugs are small molecules with molecular weights generally below 1500 daltons. We have developed and validated over 100 LC-MS/MS methods for the quantification of commercially available xenobiotics as well as for a number of novel molecules. 

These methods can be adapted and optimized for different analytical ranges, species (mouse, dog, human, etc.), biological matrices (blood, plasma, urine, etc.), more complex matrices (organs and tissues), as well as non-biological matrices (in vitro buffers, environmental samples and formulations, etc.). 

Large molecules 

The development of new drugs can also include the analysis of large molecules such as proteins. Our instruments are capable of quantifying therapeutic peptides and proteins.  

Assessment of metabolic stability in vitro: fraction S9, microsomes, and hepatocytes. 

Identification, characterization, and quantification of metabolites in vivo. 

Partial or full validation of analytical methods based on the highest quality standards in the industry (ICH, FDA).  

• Partial validation, qualification, or method adaptation 
  
  includes determination of sensitivity, selectivity, linearity, as well as assessment of within batch precision and accuracy. 
• Full validation 
  
  includes determination of sensitivity, selectivity, specificity, linearity, assessment of precision and accuracy (within and between batch), reproducibility (within and between batch), stability (short- and long-term, sensitivity to freeze/thaw cycles), matrix effect and recovery.

• Sample preparation and extraction 
• Quantitative analysis of small molecules, peptides, and proteins 
• Analysis of xenobiotics and metabolites in support of PK/PD studies 
• Analysis of preclinical and clinical samples