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PK & PD Analysis

Pharmacokinetics (PK) and pharmacodynamics (PD) services including fit-for-purpose assay validation, validation according to EMA/FDA/ICH and sample analysis

PK/PD analysis services

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Pharmacokinetic (PK) and pharmacodynamic (PD) studies are crucial components of drug development that help understand how a drug interacts with the body and its target, and how the body responds to the drug. These studies provide essential information that guides dosing, safety, efficacy, and overall drug development strategies.

PK studies help establish safe dosing ranges by identifying the relationship between drug concentration and potential toxicity. This information aids in defining the maximum tolerated dose and the therapeutic window.

Our PK & PD analysis services include:

  • Assay development
  • Assay validation
  • Sample testing

Our experienced team performs assay development, assay validation, and sample analysis in different animal species, mainly rodents, and human samples, using e.g., ELISA, Meso Scale Discovery (MSD), and SPR (Biacore™) for proteins and oligonucleotides.

We validate any type of assay, however, the Mercodia assays are highly sensitive and provide high precision and accuracy in measuring drug concentrations. This is crucial for accurately characterizing the pharmacokinetic profile of a drug, including parameters like clearance, half-life, and volume of distribution. Small errors in measurement can lead to incorrect conclusions about the drug’s behavior in the body.

Having successfully completed more than 200 nonclinical to Phase II bioanalytical projects, we are proficient in adhering to regulatory guidelines set forth by the FDA, EMA, and ICH.

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CONTACT US FOR A PROJECT PROPOSAL

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Robert Almstedt

Area Sales Manager Denmark, Iceland, Norway and Sweden

(+46) 72 292 15 08 BOOK A MEETING

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WE WILL HELP YOU

Robert Almstedt

Area Sales Manager Denmark, Iceland, Norway and Sweden

(+46) 72 292 15 08 BOOK A MEETING