A new US FDA guidance requires pharmaceutical companies to integrate race and ethnicity data

2003 ◽  
Vol &NA; (1373) ◽  
pp. 3
Author(s):  
&NA;
Molecules ◽  
2021 ◽  
Vol 26 (13) ◽  
pp. 3789
Author(s):  
Mohammad Hailat ◽  
Israa Al-Ani ◽  
Mohammed Hamad ◽  
Zainab Zakareia ◽  
Wael Abu Dayyih

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.


2016 ◽  
Vol 32 (7) ◽  
pp. 993-1017
Author(s):  
Min Zhan ◽  
Xiaoling Xiang ◽  
William Elliott

This study examines the association between educational loans and college graduation rates, with a focus on differences by race and ethnicity. Data come from the 1997 National Longitudinal Survey of Youth. Results from the event history analyses indicate that educational loans are positively related to college graduation rates, but only up to a point (about US$19,753). Although this nonlinear relationship holds true among White, Black, and Hispanic students, there are differences in the level of loans where its effect turns negative on graduate rates. There is little evidence overall that educational loans reduce racial and ethnic disparities in college graduation.


2015 ◽  
Vol 18 (4) ◽  
pp. 396-403 ◽  
Author(s):  
Han-Chung Lien ◽  
Chen-Chi Wang ◽  
Shou-Wu Lee ◽  
Jeng-Yuan Hsu ◽  
Hong-Zen Yeh ◽  
...  

JAMA ◽  
2019 ◽  
Vol 321 (12) ◽  
pp. 1217 ◽  
Author(s):  
John Heintzman ◽  
Miguel Marino

2007 ◽  
Vol 42 (6p2) ◽  
pp. 2373-2388 ◽  
Author(s):  
Donna D. McAlpine ◽  
Timothy J. Beebe ◽  
Michael Davern ◽  
Kathleen T. Call

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

Cureus ◽  
2022 ◽  
Author(s):  
Ruben D Vega Perez ◽  
Lyndia Hayden ◽  
Jefri Mesa ◽  
Nina Bickell ◽  
Pamela Abner ◽  
...  

10.2196/24288 ◽  
2021 ◽  
Vol 7 (4) ◽  
pp. e24288
Author(s):  
Peace Ossom-Williamson ◽  
Isaac Maximilian Williams ◽  
Kukhyoung Kim ◽  
Tiffany B Kindratt

Background There is an urgent need for consistent collection of demographic data on COVID-19 morbidity and mortality and sharing it with the public in open and accessible ways. Due to the lack of consistency in data reporting during the initial spread of COVID-19, the Equitable Data Collection and Disclosure on COVID-19 Act was introduced into the Congress that mandates collection and reporting of demographic COVID-19 data on testing, treatments, and deaths by age, sex, race and ethnicity, primary language, socioeconomic status, disability, and county. To our knowledge, no studies have evaluated how COVID-19 demographic data have been collected before and after the introduction of this legislation. Objective This study aimed to evaluate differences in reporting and public availability of COVID-19 demographic data by US state health departments and Washington, District of Columbia (DC) before (pre-Act), immediately after (post-Act), and 6 months after (6-month follow-up) the introduction of the Equitable Data Collection and Disclosure on COVID-19 Act in the Congress on April 21, 2020. Methods We reviewed health department websites of all 50 US states and Washington, DC (N=51). We evaluated how each state reported age, sex, and race and ethnicity data for all confirmed COVID-19 cases and deaths and how they made this data available (ie, charts and tables only or combined with dashboards and machine-actionable downloadable formats) at the three timepoints. Results We found statistically significant increases in the number of health departments reporting age-specific data for COVID-19 cases (P=.045) and resulting deaths (P=.002), sex-specific data for COVID-19 deaths (P=.003), and race- and ethnicity-specific data for confirmed cases (P=.003) and deaths (P=.005) post-Act and at the 6-month follow-up (P<.05 for all). The largest increases were race and ethnicity state data for confirmed cases (pre-Act: 18/51, 35%; post-Act: 31/51, 61%; 6-month follow-up: 46/51, 90%) and deaths due to COVID-19 (pre-Act: 13/51, 25%; post-Act: 25/51, 49%; and 6-month follow-up: 39/51, 76%). Although more health departments reported race and ethnicity data based on federal requirements (P<.001), over half (29/51, 56.9%) still did not report all racial and ethnic groups as per the Office of Management and Budget guidelines (pre-Act: 5/51, 10%; post-Act: 21/51, 41%; and 6-month follow-up: 27/51, 53%). The number of health departments that made COVID-19 data available for download significantly increased from 7 to 23 (P<.001) from our initial data collection (April 2020) to the 6-month follow-up, (October 2020). Conclusions Although the increased demand for disaggregation has improved public reporting of demographics across health departments, an urgent need persists for the introduced legislation to be passed by the Congress for the US states to consistently collect and make characteristics of COVID-19 cases, deaths, and vaccinations available in order to allocate resources to mitigate disease spread.


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