The role of quantitative safety evaluation in regulatory decision making of drugs von Chakravarty, Aloka G., Izem, Rima, Keeton, Stephine, Kim, Clara Y., Levenson, Mark S., Soukup, Mat

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Building a roadmap to biomarker qualification: challenges and opportunities von Amur, Shashi G, Sanyal, Sarmistha, Chakravarty, Aloka G, Noone, Marianne H, Kaiser, James, McCune, Susan, Buckman-Garner, ShaAvhree Y

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Real-world utilization of SARS-CoV-2 serological testing in RNA positive patients across the United States von Rodriguez-Watson, Carla V, Sheils, Natalie E, Louder, Anthony M, Eldridge, Elizabeth H, Lin, Nancy D, Pollock, Benjamin D, Gatz, Jennifer L, Grannis, Shaun J, Vashisht, Rohit, Ghauri, Kanwal, Valo, Gina, Chakravarty, Aloka G, Lasky, Tamar, Jung, Mary, Lovell, Stephen L, Major, Jacqueline M, Kabelac, Carly, Knepper, Camille, Leonard, Sandy, Embi, Peter J, Jenkinson, William G, Klesh, Reyna, Garner, Omai B, Patel, Ayan, Dahm, Lisa, Barin, Aiden, Cooper, Dan M, Andriola, Tom, Byington, Carrie L, Crews, Bridgit O, Butte, Atul J, Allen, Jeff

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Design and analysis choices for safety surveillance evaluations need to be tuned to the specifics of the hypothesized drug-outcome association von Gruber, Susan, Chakravarty, Aloka, Heckbert, Susan R., Levenson, Mark, Martin, David, Nelson, Jennifer C., Psaty, Bruce M., Pinheiro, Simone, Reich, Christian G., Toh, Sengwee, Walker, Alexander M.

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Design and analysis choices for safety surveillance evaluations need to be tuned to the specifics of the hypothesized drug-outcome association: Safety Study Design and Analysis Cho... von Gruber, Susan, Chakravarty, Aloka, Heckbert, Susan R., Levenson, Mark, Martin, David, Nelson, Jennifer C., Psaty, Bruce M., Pinheiro, Simone, Reich, Christian G., Toh, Sengwee, Walker, Alexander M.

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Characteristics of study design and elements that may contribute to the success of electronic safety monitoring systems von Bell, Carlos, Chakravarty, Aloka, Gruber, Susan, Heckbert, Susan R., Levenson, Mark, Martin, David, Nelson, Jennifer C., Pinheiro, Simone, Psaty, Bruce M., Reich, Christian G., Schneeweiss, Sebastian, Shoaibi, Azadeh, Toh, Sengwee, Walker, Alexander M.

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Characteristics of study design and elements that may contribute to the success of electronic safety monitoring systems: FACTORS FOR SUCCESS OF ELECTRONIC DRUG SAFETY SURVEILLANCE von Bell, Carlos, Chakravarty, Aloka, Gruber, Susan, Heckbert, Susan R., Levenson, Mark, Martin, David, Nelson, Jennifer C., Pinheiro, Simone, Psaty, Bruce M., Reich, Christian G., Schneeweiss, Sebastian, Shoaibi, Azadeh, Toh, Sengwee, Walker, Alexander M.

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