1. A US Food and Drug Administration perspective on evaluating medical products for Ebola. (February 2016) Authors: Russek-Cohen, Estelle; Rubin, Daniel; Price, Dionne; Sun, Wellington; Cox, Edward; Borio, Luciana Journal: Clinical trials Issue: Volume 13:Number 1(2016) Page Start: 105 Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗
2. CBER's Experience With Adaptive Design Clinical Trials. (March 2016) Authors: Lin, Min; Lee, Shiowjen; Zhen, Boguang; Scott, John; Horne, Amelia; Solomon, Ghideon; Russek-Cohen, Estelle Journal: Therapeutic innovation & regulatory science Issue: Volume 50:Number 2(2016:Mar.) Page Start: 195 Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗
3. Checking distributional assumptions for pharmacokinetic summary statistics based on simulations with compartmental models. Issue 5 (3rd September 2017) Authors: Shen, Meiyu; Russek-Cohen, Estelle; Slud, Eric V. Journal: Journal of biopharmaceutical statistics Issue: Volume 27:Issue 5(2017) Page Start: 756 Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗
4. Logistic Regression Likelihood Ratio Test Analysis for Detecting Signals of Adverse Events in Post-market Safety Surveillance. Issue 6 (2nd November 2017) Authors: Nam, Kijoeng; Henderson, Nicholas C.; Rohan, Patricia; Woo, Emily Jane; Russek-Cohen, Estelle Journal: Journal of biopharmaceutical statistics Issue: Volume 27:Issue 6(2017) Page Start: 990 Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗
5. Penalized Logistic Regression Likelihood Ratio Test Analysis to Detect Signals of Adverse Events From Interactions in Postmarket Safety Surveillance. (2nd October 2021) Authors: Nam, Kijoeng; Henderson, Nicholas C.; Rohan, Patricia; Russek-Cohen, Estelle Journal: Statistics in biopharmaceutical research Issue: Volume 13:Number 4(2021) Page Start: 405 Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗
6. Seeking harmony: estimands and sensitivity analyses for confirmatory clinical trials. (August 2016) Authors: Mehrotra, Devan V; Hemmings, Robert J; Russek-Cohen, Estelle Journal: Clinical trials Issue: Volume 13:Number 4(2016) Page Start: 456 Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗
7. Sources of Safety Data and Statistical Strategies for Design and Analysis: Real World Insights. (March 2018) Authors: Marchenko, Olga; Russek-Cohen, Estelle; Levenson, Mark; Zink, Richard C.; Krukas-Hampel, Michelle R.; Jiang, Qi Journal: Therapeutic innovation & regulatory science Issue: Volume 52:Number 2(2018:Mar.) Page Start: 170 Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗
8. Sources of Safety Data and Statistical Strategies for Design and Analysis: Transforming Data Into Evidence. (March 2018) Authors: Ma, Haijun; Russek-Cohen, Estelle; Izem, Rima; Marchenko, Olga V.; Jiang, Qi Journal: Therapeutic innovation & regulatory science Issue: Volume 52:Number 2(2018:Mar.) Page Start: 187 Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗
9. Statistical Considerations for Cardiovascular Outcome Trials in Patients with Type 2 Diabetes Mellitus. (2nd October 2017) Authors: Marchenko, Olga; Jiang, Qi; Chuang-Stein, Christy; Mehta, Cyrus; Levenson, Mark; Russek-Cohen, Estelle; Liu, Lingyun; Sanchez-Kam, Matilde; Zink, Richard; Ke, Chunlei; Ma, Haijun; Maca, Jeff; Park, Soomin Journal: Statistics in biopharmaceutical research Issue: Volume 9:Number 4(2017) Page Start: 347 Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗