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Pharmacokinetic Testing

Pharmacokinetic Testing Services

For reproducible PK data and reliable reporting

Advanced PK Bioanalysis

During the drug research and development process, reliable pharmacokinetic (PK) and pharmacodynamic (PD) assays are required and enable investigators to make timely decisions about critical parameters such as the starting dose of a drug for a first-in-human clinical trial based on pre-clinical PK data or the evaluation of the time course of a drug in plasma after administration.

As part of your team, our scientists lend their expertise and assist you in developing a strategy that is right for your program and help you overcome any hurdles that you may face during the R&D phase.

Expert Guidance, High-Quality PK Results

Our analytical chemists are experts in liquid chromatography with tandem mass spectrometry (LC-MS/MS) techniques and specialize in complex PK assay method development and protocols to facilitate drug discovery and clinical trials programs.

Each of our scientists brings a scope of leading-edge technologies, and we have developed assays to examine multiple specimen types and tissue types.

 

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PK Bioanalysis and Beyond

Specialized in the Quantification of Drugs, Metabolites, and Biomarkers

Our analytical chemists are experts in the use of LC-MS/MS

Therapeutic Drug Monitoring

Time course measurement of a drug in a patient's bloodstream

Assay Development

Process of developing tests or measuring the activity of a chemical in a sample

Analytical Method Transfer

A GMP required process that qualifies a receiving lab to use a method originated in the transferring lab

  • Comparative testing-comparison of obtained results by the receiving and transferring labs
  • Cross validation-the receiving and transfer labs perform different parts of the validation
  • Revalidation-the receiving lab performs the validation   

Method Development

Verification that an analytical method is acceptable for accurately measuring the concentration of a specific drug

Discovery Bioanalysis

Bioanalysis performed during the discovery phase of a drug R&D program

Preclinical R&D and Clinical Research

Bioanalysis performed during phase 1 through phase IV of a drug R&D program

FIM Studies with Quick Turnaround Times

Rapid delivery of results to support first in human studies

Final MAA & NDA Submissions

Submission of Marketing Authorization Application & New Drug Application

Old Drugs in New Formulations

Modifications to formulation of existing drugs or changes in delivery methods

Epidemiological Health Surveys

Bioanalytical studies to support various health survey projects

Reporting and Trend Analysis of Study Data

Reliable data reporting and analysis provided to support the needs of each client

Consultancy Services

Our experts are available to provide guidance at any point during your studies

Pharmacokinetic testing

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