title: New US FDA draft guidance on bioanalytical method validation versus current FDA and EMA guidelines: chromatographic methods and ISR.
authors.affiliation: Zimmer BioAnalytics & More, St. Alban-Ring 282, CH-4052, Basel, Switzerland. dzimmer@zbam.eu.
authors.forename: Dieter
authors.initials: D
authors.lastname: Zimmer
mesh_terms: D002138:Calibration; D002845:Chromatography / Q000592:standards*; D004355:Drug Stability; D005060:Europe; D006801:Humans; D057230:Limit of Detection; D017410:Practice Guidelines as Topic; D012015:Reference Standards; D015203:Reproducibility of Results; D014481:United States; D014486:United States Food and Drug Administration; D054928:Validation Studies as Topic