We offer you full support for non-clinical and clinical studies

Bioanalysis (determination of substance concentration in biological samples) is an essential element of drug development processes in the pharmaceutical industry. The quantitative measurement of the active compound and/or its metabolite(s) provides data for pharmacokinetic/toxicokinetic evaluation in order to assess systemic exposure. The data is used – among others – in the interpretation of toxicology findings and in assessing their relevance in terms of clinical safety issues.

Validation in accordance with GLP regulations is carried out in compliance with the latest FDA, EMA and ICH guidelines. These requirements apply to all developmental stages.

We can offer you full support for non-clinical and clinical studies as well as our expertise and a wide range of bioanalytical platforms for small molecules:

• Quick method development / method transfer using the most appropriate techniques:
• LC-MS/MS, HPLC-UV, ELISA, radiometry: 14C, 3H, 125I, 32P
• Analysis of solutes in various matrices (plasma, tissues, excreta, etc.) of different species
• Pharmacokinetic, toxicokinetic and statistical evaluation with acknowledged and validated tools (WinNonLin, SAS)

Analysis of non-clinical study samples from a broad range of studies:

• Pharmacokinetics/toxicokinetics
• Tissue distribution
• Metabolism studies
• Biopharmaceutical development

Reliable support for clinical trials:

• Contribution to phase I to IV trials with
  • Study design (sampling times and wash-out period)
  • Operational manual for sampling and sample handling
• Analysis of the active substance and/or its metabolite(s) in human plasma, or other matrices for pharmacokinetic and exposure assessment in humans
  • Bioavailability and bioequivalence
  • Food interaction
  • Drug-drug interaction
  • Special patient population studies
• Human metabolism studies following the administration of radio-labelled or cold active substances
  • Metabolite profiling
  • Metabolite identification

Additionally, we are able to support you with our experience in complex methods, difficult solutes and analytically challenging compounds, e.g.

• amphipathic compounds containing long alkyl chains
• highly polar or highly basic compounds
• peptide derivatives with hydrophobic moieties.

 

For further information please feel free to start a conversation.

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