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.
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.
Our analytical chemists are experts in the use of LC-MS/MS
Time course measurement of a drug in a patient's bloodstream
Process of developing tests or measuring the activity of a chemical in a sample
A GMP required process that qualifies a receiving lab to use a method originated in the transferring lab
Verification that an analytical method is acceptable for accurately measuring the concentration of a specific drug
Bioanalysis performed during the discovery phase of a drug R&D program
Bioanalysis performed during phase 1 through phase IV of a drug R&D program
Rapid delivery of results to support first in human studies
Submission of Marketing Authorization Application & New Drug Application
Modifications to formulation of existing drugs or changes in delivery methods
Bioanalytical studies to support various health survey projects
Reliable data reporting and analysis provided to support the needs of each client
Our experts are available to provide guidance at any point during your studies