Subhanjaneya Raju

13 years Research experience in the area of analysis of endogenious compounds, Drugs and their metabolites in biological matrices. Proficient knowledge on Method development and Validation of Drug(s) and its Metabolite(s) in biological matrices as per the regulatory requirements. Acquired Knowledge on in-house standard operating procedures, instrument calibration and validation.Very good at literature survey.

• Date of Birth: 08/10/87
• Nationality: Indian
• Marital Status: Married

• Concomitant drugs interference of the volunteer sample analysis in a bio study.
• Bio equivalence and bio availability studies.
• Performing extraction procedures like liquid phase extraction, solid phase extraction and precipitation methods.

• Method Development: Literature survey, Cmax, Physiochemical properties, Solubility, Molecular weight, Formula weight, Linearity range, Stock weighing, Preparation of tuning solutions, Mobile phase optimization, Column optimization, Method optimization, Premethod validation, selection of weighing factor and Preparation of method SOP.
• Method Validation: perform method validation as per regulatory like ANVISA, US-FDA, EMEA, UK-MHRA. System suitability, Auto sampler carry over, Selectivity/Specificity, Matrix effect, P&As, Long P&A, Recovery, Reinjection-reproducibility, Ruggedness, Stabilities. Concomitant medication.
• Project Sample Analysis: Stock weighing, Spiking solutions preparation, Bulk spiking, Preparation of analytical batch sequence, Sample processing, Batch acquire, Check the analytical batch acceptance, ISR Selection, ISR Sample processing, check the ISR acceptance.
• Calibrations: HPLC and Monitoring the MS Calibration.