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 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 Development and Validation of a Method for Quantification of Favipiravir as COVID-19 Management in Spiked Human Plasma

Molecules ◽  
2021 ◽  
Vol 26 (13) ◽  
pp. 3789
Author(s):  
Mohammad Hailat ◽  
Israa Al-Ani ◽  
Mohammed Hamad ◽  
Zainab Zakareia ◽  
Wael Abu Dayyih
Keyword(s):  
Human Plasma ◽  
Internal Standard ◽  
Weighting Factor ◽  
Hplc Method ◽  
Bioanalytical Method Validation ◽  
Spiked Human Plasma ◽  
Fda Guidance ◽  
Significant Difference ◽  
Us Fda ◽  
Carry Over

In the current work, a simple, economical, accurate, and precise HPLC method with UV detection was developed to quantify Favipiravir (FVIR) in spiked human plasma using acyclovir (ACVR) as an internal standard in the COVID-19 pandemic time. Both FVIR and ACVR were well separated and resolved on the C18 column using the mobile phase blend of methanol:acetonitrile:20 mM phosphate buffer (pH 3.1) in an isocratic mode flow rate of 1 mL/min with a proportion of 30:10:60 %, v/v/v. The detector wavelength was set at 242 nm. Maximum recovery of FVIR and ACVR from plasma was obtained with dichloromethane (DCM) as extracting solvent. The calibration curve was found to be linear in the range of 3.1–60.0 µg/mL with regression coefficient (r2) = 0.9976. However, with acceptable r2, the calibration data’s heteroscedasticity was observed, which was further reduced using weighted linear regression with weighting factor 1/x. Finally, the method was validated concerning sensitivity, accuracy (Inter and Intraday’s % RE and RSD were 0.28, 0.65 and 1.00, 0.12 respectively), precision, recovery (89.99%, 89.09%, and 90.81% for LQC, MQC, and HQC, respectively), stability (% RSD for 30-day were 3.04 and 1.71 for LQC and HQC, respectively at −20 °C), and carry-over US-FDA guidance for Bioanalytical Method Validation for researchers in the COVID-19 pandemic crisis. Furthermore, there was no significant difference for selectivity when evaluated at LLOQ concentration of 3 µg/mL of FVIR and relative to the blank.

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
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