Bioanalytics

Pharmacelsus provides state-of-the-art equipment to obtain the most sensitive bioanalytical method possible.


 

Bioanalytical Services - Non-GLP

More than once, Pharmacelsus has been successfully challenged to crack tough nuts in bioanalytics for small molecules or phyto-pharmaceuticals.

For externally or in-house generated samples, Pharmacelsus provides

  • Sample preparation
    • Protein precipitation
    • Liquid / Liquid extraction
    • Solid Phase Extraction
    • Tissue homogenization and extraction
  • Drug plasma/serum quantification
  • Tissue level quantification
  • Urine/faeces level quanitification
  • Dose formulation analysis
  • Biomarkers / Immunoassays
  • Biotransformation profiles
  • Metabolite identification
  • Metabolite characterisation according to FDA guidance for industry, safety testing of drug metabolites

 

Metabolite Characterization according to the FDA guidance for industry, Safety testing of drug metabolites

LC-MS vials

Since each drug is subjected to metabolism when it enters an organism, the resulting metabolites can be toxic or pharmacologically active.

As a consequence, the FDA insists on the identification of metabolites and their safety evaluation as described in the guidance for industry, "safety testing of drug metabolites", FDA, February 2008. The characterization of metabolites by LC-MS is done routinely by Pharmacelsus.