New US FDA draft guidance on bioanalytical method validation versus current FDA and EMA guidelines: chromatographic methods and ISR

MeSH terms

• Calibration
• Chromatography / standards*
• Drug Stability
• Europe
• Humans
• Limit of Detection
• Practice Guidelines as Topic*
• Reference Standards
• Reproducibility of Results
• United States
• United States Food and Drug Administration
• Validation Studies as Topic