FDA-konforme Validierung analytischer Methoden
Dr. Thomas Trantow
Analytik-Service Dr. T. Trantow, Schöneiche bei Berlin
FDA-conformable Validation of Analytical Methods
The following article starts with an overview of the current FDA regulations concerning the validation of analytical methods, including current draft guidances relevant to validation. Prerequisites for validation, the content of method descriptions, basic thoughts about statistics, the meaning of raw data as well as principles for a validation protocol and a validation report are presented under ’fundamental requirements’.
pharmind 2005, Nr. 4, Seite 462