Tejaskumar Thakkar Email & Phone Number

Development of new LC-MS/MS methods for the quantitation of drugs and their metabolites in biological samples.Literature Review on Drugs basic information, Pharmacokinetics and physicochemical properties.Perform Tuning activity of Drugs, ISTD and their Metabolites on LC/MS for Optimization of Mass Parameters.Optimization of Chromatographic Condition with knowledge of buffers trials used in Mobile phase and selection of column. Aware about types of columns, properties and Uses.Optimization of Extraction Techniques for drugs and their metabolites from biological samples and different matrix with knowledge of Extraction techniques used like Protein Precipitation, Liquid-Liquid Extraction and Solid Phase Extraction.Perform Pre-Method Validation Experiments to ensure and finalization of Method.Known to APCI- Atmospheric pressure chemical ionization and ESI - Electrospray ionization techniques.Prepare STP(s) (Standard Test Procedures) to support method validation activity.Manages Study Sample receive process and Storage activities.Review of BE Protocols and clinical updates according to Regulatory Guidance (USFDA & DCGI).Providing Training of Study Protocol and clinical updates with consideration of method validation parameters.Manage schedule to complete analysis of study samples within timeline.Review of Chromatograms, data preparation, data compilation.ISR sample selection and Repeat analysis.Evaluation of Pilot study results for the initiation of Pivotal study.Prepares documents for Quality Control and Quality Assurance reviews. Preparation and updating of BE Study Summary Report and concentration profile.Review of Complete Analytical Results.

Listed skills include Ph Meter Calibration And Operation, Anvisa, Equipment Maintenance, Usfda, and 47 others.