Please enable JavaScript.
Coggle requires JavaScript to display documents.
Validation/Method Validation, ICH-Q2R1/Q2A "Text on Validation of…
-
- ICH-Q2R1/Q2A "Text on Validation of Analytical Procedure (1994)"
- ICH-Q2R1/Q2B "Validation of Analytical Procedures Methodology"
- CDER "Reviewer Guidance: Validation of Chromatographic Method (1994)"
- CDER "Submitting Samples and Analytical Data for Method Validations (1987)"
- CDER Draft "Analytical Procedures and Method Validation (2000)"
- CDER "Bioanalytical Method Validation for Human Studies (1999)"
- USP <1225> "Validation of Compendial Methods"
is the process by which it is established, by laboratory studies, that the performance characteristics of the procedure meet the requirements for the intended analytical applications.