Therapeutic Drug Monitoring

The therapeutic drug monitoring facility in the Department of Haematology is well equipped with state of the art High Performance Liquid chromatography systems with Ultraviolet, Fluorescence, PDA and refractive index detectors. In addition, two quadrupole mass-spectrometers (API 2000 and Shimadzu LC-MS/MS 8050) are also available for both routine service and research use.

The list of major equipment available in the TDM laboratory include:

• API 2000 Mass Spectrometer with Shimadzu LC20 AD UFLC and UV detector.
• Shimadzu LC20 AD HPLC with SPD-M20A PDA detector, RF10AXL Fluorescence detector.
• Shimadzu Ultra-FAST LCMS 8050 TQ Mass Spectrometer with ESI and Nexra LC30AD.
• Horizon Technology USA Xcel Vap Nitrogen Evaporator.
• Powder safe Type A ductless hood AC710-C2147.

The staff are trained with instrument operation, troubleshooting as well as new method development and validation, depending on the need.

The TDM laboratory currently provides cyclosporine trough levels and Busulfan Area under the curve routinely in the service mode. The lab participates in external quality assurance scheme for cyclosporine assay (RCPA- Australia). The TDM laboratory also participates in various clinical trials carried out in the department performing pharmacokinetic studies.

Several other drug assays (cyclophosphamide and metabolites, imatinib, Dasatinib, nilotinib, fludarabine, treosulfan, melphalan) are being carried out in research mode with generous funding from various funding agencies including Wellcome- DBT Indian Alliance (LC-MS/MS 8050), and Department of Biotechnology, India and CEFIPRA. Using pharmacokinetic software, population pharmacokinetic models are developed to understand the factors influencing inter-individual variability in drug PK. If and once the optimum target drug levels are identified, TDM will be done for these drugs as well, depending on the clinical need.