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Bio Analytical Training
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Regulated Bio Analysis with LC-MS
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Bio Analysis with LC-MS
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Regulated Bio Analysis
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Regulated Bio Analysis with LC-MS (Theory and on-site training)
Duration: 1 Month (Part Time)
Scope of Bio Analysis in Drug Discovery
Over view of Drug Development
Pre clinical Development
Clinical Development
Sample preparation technique like Protein Precipitate, Liquid-Liquid, Solid Phase. etc
Basic Fundamentals of Mass Spectrometry
Principal of Major Mass Spectrometer like Ion-Trap, Triple Quadruple, TOF, etc
Use of Mass Spectrometer
Application of LC-MS and UPLC-MS(Triple Quadrupole) which includes:
Optimization of MS Condition for Particular Analyte
Setting Up the Chromatographic and MS Paramete
Quantitative Analysis of Analyte
Validation of Bio analytical method as per FDA and EMEA
Specificity, Selectivity
Precision and accuracy
Recovery and Matrix Effect
Stability:
Wet extract/ Auto Sampler, Bench Top
Freeze Thaw
Long storage for stock, Dilution and Bio Samples
ISRA
Requirement of Partial Validation
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