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Bioanalytical Services
Our Bioanalytical Group at Absorption Systems provides quantitative measurements on a range of active drugs (small molecules to peptides) or metabolite(s) in biological matrices such as plasma, serum, urine, feces, bile and tissues.
The group's capabilities include:
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Performance of both GLP-compliant and non-GLP method development for bioanalysis and sample preparation
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Performance of bioanalytical work with the rigor required to satisfy regulatory agencies such as the United States FDA
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Support of ADME screening, preclinical pharmacokinetic (PK) and toxicokinetic (TK) studies
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Performance of GLP bioanalysis of plasma samples from human clinical trials
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Handling projects ranging in size from a few to several thousand samples
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Analysis of thousands of samples a week using LC-MS/MS
- Bioanalytical method development and transfer
Instrumentation includes
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Thermo Scientific LTQ Orbitrap XL
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Applied Biosystems Q TRAP LC-MS/MS System
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Applied Biosystems API 4000s
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Leap CTC Analytics Autosamplers
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Tomtec Quadra 96 robotic sample prep workstation
LC-MS/MS data is generated using Analyst® Version 1.4.1 compliant with 21 CFR Part 11, and all customer reports are archived in a validated NuGenesis 7.0 database compliant with 21 CFR Part 11.
All bioanalytical projects, from the simplest sample preparation to the most complex method validation, are approached with a focus on accuray, precision, efficiency, and speed.
Please contact Absorption Systems to learn how the Bioanalytical group can assist you in your next project.
