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Bioanalytical Research Laboratory at FCRL is involved in the analysis of drugs and / or active metabolites from biological matrices in support of Bioavailability (BA), Bioequivalence (BE) and Pharmacokinetic (PK) studies as part of the early clinical development programs. We also undertake bioanalysis for Therapeutic Drug Monitoring (TDM) studies. The laboratory offers development, validation and application of the analytical methods for various pharmacologically active moieties in different biological matrices. With the state-of-the-art instrumentation including LC-MS/MS and HPLC, the laboratory provides services to meet the quality parameters as well as timelines. With its highly skilled and experienced researchers, the laboratory possesses competency in development, validation and transfer of the bioanalytical method.
Our functions follow applicable GLP principles with comprehensive SOPs implemented for various activities in the laboratory. Each activity is closely monitored by the QA personnel for compliance with SOPs, protocol as well as applicable national and international regulatory requirements. At FCRL, we are committed to provide quality bioanalytical services with rapid turnaround time.
Bioanalytical laboratory features:
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Sample processing labs to handle light sensitive molecules. |
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Walk-in cold rooms (-20 degree Celsius) and deep freezers (-80 degree Celsius) for storage |
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LCMS/MS of latest makes (API 4000/3000) |
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Analyst (version 1.4.1) with disaster management system. |
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| List of assays |
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