Services > Bioanalytics

Our department Bioanalytics is characterised with the long-time experience in the quantification of drugs and metabolites in biological matrices. Our services, used methods, experience as well as the list of drugs which we have analysed are described in the following.


Services of the department Bioanalytics (GLP, GCP)
  • Draw up of analytical protocols
  • Method development for the determination of drugs and metabolites in biological matrices
  • Validation (pre-study validation) of the methods according to the relevant FDA and EU guidelines
  • Quantification of the drugs and metabolites within studies according to the relevant FDA and EU guidelines
  • Storage of the biological samples at -20 °C or -80 °C under continuous temperature control (validated software, annually calibrated, 24-hour centralised alarm system)
  • Draw up of analytical reports
  • GLP and GCP conformed documentation and archiving

Method and Equipment
The main focus of used methods are based on chromatography. The following techniques are used:
  • LC-MS/MS
  • HPLC-UV; HPLC-Fluorescence
  • GC-MS

Experience
  • ACC GmbH Analytical Clinical Concepts has been involved in more than 400 studies. The analytical methods are described in more than 220 method-SOPs as well as the data that are documented in the respective validation reports
  • Following matrices were investigated within clinical trials:
    Blood, plasma, serum, urine, saliva, sputum
  • Following matrices were investigated within animal trials:
    Plasma, serum, urine, tissues (muscle, liver, kidney, skin, fat), milk, eggs
  • The investigated drugs/metabolites covers the whole spectrum of drug classes

List of drugs and methods
Please find here our actual list of drugs and methods
  • There are always new methods which are developed and validated. Depending on the drug, we would be able to develop and validate methods within 2-3 weeks
  • Please contact us, if you do not find your considered drug in the list. We will inform you about the actual status of development.

Capacity
  • 80.000 to 100.000 samples/year
  • 50-60 studies/year