New US FDA draft guidance on bioanalytical method validation versus current FDA and EMA guidelines: chromatographic methods and ISR

Bioanalysis ◽  
2014 ◽  
Vol 6 (1) ◽  
pp. 13-19 ◽  
Author(s):  
Dieter Zimmer
Keyword(s):  
Method Validation ◽  
Draft Guidance ◽  
Bioanalytical Method Validation ◽  
Bioanalytical Method ◽  
Chromatographic Methods ◽  
Us Fda

8th GCC: Consolidated feedback to US FDA on the 2013 Draft FDA Guidance on Bioanalytical Method Validation

Bioanalysis ◽  
2014 ◽  
Vol 6 (22) ◽  
pp. 2957-2963 ◽  
Author(s):  
Joseph Bower ◽  
Douglas Fast ◽  
Fabio Garofolo ◽  
Dominique Gouty ◽  
Roger Hayes ◽  
...  
Keyword(s):  
Method Validation ◽  
Bioanalytical Method Validation ◽  
Bioanalytical Method ◽  
Fda Guidance ◽  
Us Fda

Conference Report: AAPS and US FDA Crystal City V meeting on Quantitative Bioanalytical Method Validation and Implementation: feedback from the EBF

Bioanalysis ◽  
2014 ◽  
Vol 6 (6) ◽  
pp. 729-732 ◽  
Author(s):  
John Smeraglia ◽  
Stuart McDougall ◽  
Karen Elsby ◽  
Arjen Companjen ◽  
Stephen White ◽  
...  
Keyword(s):  
Method Validation ◽  
Conference Report ◽  
Bioanalytical Method Validation ◽  
Bioanalytical Method ◽  
Us Fda

scholarly journals Recommendations and Best Practices for Reference Standards and Reagents Used in Bioanalytical Method Validation

2014 ◽  
Vol 16 (2) ◽  
pp. 352-356 ◽  
Author(s):  
Joseph F. Bower ◽  
Jennifer B. McClung ◽  
Carl Watson ◽  
Takahiko Osumi ◽  
Kátia Pastre
Keyword(s):  
Best Practices ◽  
Method Validation ◽  
Reference Standards ◽  
Bioanalytical Method Validation ◽  
Bioanalytical Method

Bioanalytical Method Validation for Macromolecules in Support of Pharmacokinetic Studies

2005 ◽  
Vol 22 (9) ◽  
pp. 1425-1431 ◽  
Author(s):  
JoMarie Smolec ◽  
Binodh DeSilva ◽  
Wendell Smith ◽  
Russell Weiner ◽  
Marian Kelly ◽  
...  
Keyword(s):  
Method Validation ◽  
Pharmacokinetic Studies ◽  
Bioanalytical Method Validation ◽  
Bioanalytical Method

Lights and Shadows of the Actual European Guidelines on Bioanalytical Method Validation

2014 ◽  
Vol 36 (6) ◽  
pp. 739-745 ◽  
Author(s):  
Sara Baldelli ◽  
Dario Cattaneo ◽  
Serena Fucile ◽  
Emilio Clementi
Keyword(s):  
Method Validation ◽  
Bioanalytical Method Validation ◽  
Bioanalytical Method ◽  
European Guidelines
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