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Services We Provide
Bioanalytical Support
KAR Bioanalytical, Inc. provides analytical method development and validation services to support all levels of pharmaceutical development. We have extensive experience in the quantitation of drugs and metabolites in plasma, serum, urine, feces, and a variety of tissues. With our list of instrumentation (see below), we can provide support to a broad range of matrices and analytes.
Formulations
KAR Bioanalytical, Inc. provides analytical method development and analysis of formulation samples for pre-clinical studies. We have worked with aqueous solutions and suspensions, oils, and feeds. Our variety of instrumentation allows us to take on some rather unusual analytes.
Pharmacokinetics/Toxicokinetics
KAR Bioanalytical, Inc. can provide non-compartmental kinetic analysis. We use Watson® LIMS, to provide the calculations and summary reports for kinetics.
Instrumentation
KAR Bioanalytical, Inc. has four LC-MS/MS systems; two Micromass Quattro instruments and two Sciex 3000 instruments. Additionally, we have 5 Waters HPLC systems with UV, Fluorescence, and Refractive Index detectors.
Volatile and semi-volatile compounds are best analyzed by gas chromatography. We have GC instrumentation to handle those analyses. Detectors include FID, ECD, ELCD, and NPD as well as mass spectrometry.
Metals are frequently incorporated into pharmaceuticals. KAR Laboratories can analyze for metals using atomic absorption (AA), inductively-coupled plasma (ICP), ICP-MS, and flame emission spectrometry.
KAR Bioanalytical, Inc. has low temperature sample storage at either -20º or -70º. All of our freezers are monitored 24/7 by an outside monitoring company. We are notified within minutes of any temperature event outside of our specifications.
Software
KAR Bioanalytical, Inc. uses validated software to process data and generate reports. These validated systems include . . .
- Waters Millennium® for HPLC systems
- Waters MassLynx® for MicroMass LC-MS/MS systems
- Sciex Analyst® for Sciex systems
- Watson® LIMS for documenting study design and sample receipt, scheduling analytical runs, interfacing with analytical instruments, regressing analytical results, and analyzing and summarizing the resulting concentrations and pharmacokinetic data
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Regulatory
KAR Bioanalytical, Inc. has a full functioning internal quality assurance (QA) department. QA is an independent group that reports directly to the president. QA performs in-study inspections, reviews all data and reports, issues reports of findings to internal management and study directors, provides training, and implements and maintains GLP document requirements.
All GLP-compliant analyses are performed following internal or sponsor-supplied SOPs. Method validations are performed in accordance with “Guidance for Industry, Bioanalytical Method Validation” issued May 2001.
KAR Bioanalytical, Inc. has been inspected by the FDA, most recently in February 2005. We have passed all of our FDA inspections and have never received a 483 observation. Our sponsors have audited us on numerous occasions with no major findings.
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