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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 (Theory Site Tour)
Duration: 15 Days (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
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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