BioPharma Services >> Bioanalysis >> PK

Pharmacokinetic /Toxicokinetic (PK/TK)

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Pharmacokinetic /Toxicokinetic (PK/TK) analysis of biopharmaceutical drugs requires different solutions from those traditionally employed in the analysis of small molecules. We have industry-leading experience in the development and validation of PK/TK assays for the measurement of large molecules and peptides.

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Pharmacokinetic/Toxicokinetic Analysis Services

When you outsource your PK/TK bioanalysis to Eurofins Bioanalytical Services, you get more than just a service organization: you get access to the top minds in science. We'll deliver the fast, quality results you expect and the insight that comes from years of experience, deep resources and flexible service options. You'll have the support you need for every phase of your project. 

 

Method Transfer

Transfer and optimization of non-validated or validated assays to client specifications

Method Development

To provide the best analytical solution for the broadest range of matrices and species, we:

  • Develop and validate assays that have analytical ranges appropriate for what is expected in the study samples
  • Develop assays that are both  specific and sensitive
  • Provide support for adaptation of any commercially available reagents or critical reagent generation and purification including the generation of antibodies to be used for capture or detection reagents
  • Assess method feasibility in multiple technology platforms
 

Validation

Our comprehensive services follow current FDA guidelines, AAPS white papers and the most up-to-date industry guidelines. We validate as appropriate for the nature of the assay as well as the stage in drug development.

Sample Analysis

From small GLP-compliant pre-clinical projects to large scale GCP-compliant clinical trial sample analysis, our advanced project scheduling and tracking systems offer a scale-flexible outsourcing solution. Studies not requiring GLP/GCP compliance are still performed to the same high standards under our comprehensive quality system.