scholarly journals Bioanalytical method validation: notable points in the 2009 draft EMA Guideline and differences with the 2001 FDA Guidance

Bioanalysis ◽  
2010 ◽  
Vol 2 (5) ◽  
pp. 929-935 ◽  
Author(s):  
Graeme Smith
Keyword(s):  
Method Validation ◽  
Bioanalytical Method Validation ◽  
Bioanalytical Method ◽  
Fda Guidance

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

scholarly journals Bioanalytical method validation: new FDA guidance vs. EMA guideline. Better or worse?

2019 ◽  
Vol 165 ◽  
pp. 381-385 ◽  
Author(s):  
Michał Kaza ◽  
Marta Karaźniewicz-Łada ◽  
Katarzyna Kosicka ◽  
Anna Siemiątkowska ◽  
Piotr J. Rudzki
Keyword(s):  
Method Validation ◽  
Bioanalytical Method Validation ◽  
Bioanalytical Method ◽  
Fda Guidance

scholarly journals Workshop Report: Crystal City V—Quantitative Bioanalytical Method Validation and Implementation: The 2013 Revised FDA Guidance

2014 ◽  
Vol 17 (2) ◽  
pp. 277-288 ◽  
Author(s):  
Brian Booth ◽  
Mark E. Arnold ◽  
Binodh DeSilva ◽  
Lakshmi Amaravadi ◽  
Sherri Dudal ◽  
...  
Keyword(s):  
Method Validation ◽  
Bioanalytical Method Validation ◽  
Workshop Report ◽  
Bioanalytical Method ◽  
Fda Guidance

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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