US FDA Guidance

2006 ◽  
Vol 24 (9) ◽  
pp. 833-836 ◽  
Author(s):  
Paul Kind
Keyword(s):  
Fda Guidance ◽  
Us Fda

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 Responder Definition of a Patient-Reported Outcome Instrument for Laryngopharyngeal Reflux Based on the US FDA Guidance

2015 ◽  
Vol 18 (4) ◽  
pp. 396-403 ◽  
Author(s):  
Han-Chung Lien ◽  
Chen-Chi Wang ◽  
Shou-Wu Lee ◽  
Jeng-Yuan Hsu ◽  
Hong-Zen Yeh ◽  
...  
Keyword(s):  
Laryngopharyngeal Reflux ◽  
Patient Reported Outcome ◽  
Fda Guidance ◽  
Outcome Instrument ◽  
Patient Reported ◽  
The Us ◽  
Us Fda ◽  
Definition Of

SFC-MS/MS method for simultaneous determination of nimodipine and 3-n-butylphthalide in beagle plasma: application to pharmacokinetic interaction study

Bioanalysis ◽  
2020 ◽  
Vol 12 (21) ◽  
pp. 1509-1519
Author(s):  
Weiping Wang ◽  
Pengyan Li ◽  
Mengna Fang ◽  
Xiaoting Li ◽  
Yu Zhang ◽  
...  
Keyword(s):  
High Throughput ◽  
Ammonium Acetate ◽  
Pharmacokinetic Interaction ◽  
Interaction Study ◽  
Isocratic Elution ◽  
Fda Guidance ◽  
Precipitation Procedure ◽  
Study Results ◽  
Us Fda

Aim: Nimodipine and 3-n-butylphthalide are co-administered to treat vascular dementia, but the pharmacokinetic interaction between the two drugs is still unknown. Therefore, a robust, high-throughput and economical supercritical fluid chromatography–ESI-MS/MS method has been initially developed to simultaneously determine nimodipine and 3-n-butylphthalide in beagle plasma, in order to study the safety of co-administration. Materials & methods: After a simple protein precipitation procedure, isocratic elution with mobile phase of CO2 and methanol (containing 0.3% formic acid and 2 mM ammonium acetate) was applied to minimize run time and facilitate sensitive and high-throughput bioanalysis. The method was fully validated according to US FDA Guidance. The validated method was then successfully applied in a pharmacokinetic interaction study. Results: The results indicated there is no significant pharmacokinetic interaction between the two drugs.

scholarly journals Interpreting patient-reported outcome results: US FDA guidance and emerging methods

2011 ◽  
Vol 11 (2) ◽  
pp. 163-169 ◽  
Author(s):  
Lori D McLeod ◽  
Cheryl D Coon ◽  
Susan A Martin ◽  
Sheri E Fehnel ◽  
Ron D Hays
Keyword(s):  
Patient Reported Outcome ◽  
Fda Guidance ◽  
Patient Reported ◽  
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

scholarly journals Simultaneous determination of warfarin and 7-hydroxywarfarin in rat plasma by HPLC-FLD

2020 ◽  
Vol 70 (3) ◽  
pp. 343-357 ◽  
Author(s):  
Aref Zayed ◽  
Wahby M. Babaresh ◽  
Ruba S. Darweesh ◽  
Tamam El-Elimat
Keyword(s):  
High Performance ◽  
Direct Determination ◽  
Warfarin Dose ◽  
Rat Plasma ◽  
Reversed Phase ◽  
Bioanalytical Method Validation ◽  
Fda Guidance ◽  
Us Fda ◽  
First Time

AbstractIn this study, high-performance liquid chromatography with fluorescence detection (HPLC-FLD) has been used for the first time, for direct determination of warfarin and its major metabolite, 7-hydroxywarfarin, in rat plasma. The simple and sensitive method was developed using Fortis® reversed-phase diphenyl column (150 × 4.6 mm, 3 μm) and a mobile phase composed of phosphate buffer (25 mmol L−1)/methanol/acetonitrile (70:20:10, V/V/V), adjusted to pH 7.4, at a flow rate of 0.8 mL min−1. The diphenyl chemistry of the stationary phase provided a unique selectivity for separating the structurally related aromatic analytes, warfarin and 7-hydroxywarfarin, allowing their successful quantification in the complex plasma matrix. The method was linear over the range 0.01–25 μg mL−1, for warfarin and 7-hydroxywarfarin, and was found to be accurate, precise and selective in accordance with US FDA guidance for bioanalytical method validation. The method was sensitive enough to quantify 0.01 μg mL−1 of warfarin and 7-hydroxywarfarin (LLOQ) using only 100 μL of plasma. The applicability of this method was demonstrated by analyzing samples obtained from rats after oral administration of a single warfarin dose, and studying warfarin and 7-hydroxywarfarin pharmacokinetics.

Acrylamide: US FDA Guidance to Industry

2019 ◽  
pp. 487-491
Author(s):  
Lauren Posnick Robin ◽  
Eileen Abt
Keyword(s):  
Fda Guidance ◽  
Us Fda

Compatibility of immunogenicity guidance by the EMA and the US FDA

Bioanalysis ◽  
2019 ◽  
Vol 11 (17) ◽  
pp. 1619-1629 ◽  
Author(s):  
Pekka Kurki
Keyword(s):  
Multidisciplinary Approach ◽  
Reference Product ◽  
Therapeutic Protein ◽  
European Medicines Agency ◽  
Fda Guidance ◽  
Antidrug Antibody ◽  
The Us ◽  
Antibody Assays ◽  
Us Fda

The guidelines for immunogenicity studies by the European Medicines Agency and the US FDA are based on different legislations and regulatory philosophies. In spite of the different background, the main guidelines are compatible on the scientific level, especially for new innovative therapeutic protein products. The importance of sensitive and drug-tolerant antidrug antibody assays and multidisciplinary approach to development and assessment are highlighted by both agencies. The main differences are in the field of biosimilars. The nonclinical in vivo immunogenicity studies are seen more useful by the FDA than by the European Medicines Agency. The draft FDA guidance on interchangeability will complicate global biosimilar development by requiring clinical switch studies with US sourced reference product.

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