Stratification, Hypothesis Testing, and Clinical Trial Simulation in Pediatric Drug Development

Por McMahon, Ann W., Watt, Kevin, Wang, Jian, Green, Dionna, Tiwari, Ram, Burckart, Gilbert J.
Publicado no Ther Innov Regul Sci (2016)

Surrogate Endpoints in Pediatric Studies Submitted to the US FDA

Por Green, Dionna J., Sun, Haihao, Burnham, Janelle, Liu, Xiaomei I., van den Anker, John, Temeck, Jean, Yao, Lynne, McCune, Susan K., Burckart, Gilbert J.
Publicado no Clin Pharmacol Ther (2018)

Enrichment Strategies in Pediatric Drug Development: An Analysis of Trials Submitted to the US Food and Drug Administration

Por Green, Dionna J., Liu, Xiaomei I., Hua, Tianyi, Burnham, Janelle M., Schuck, Robert, Pacanowski, Michael, Yao, Lynne, McCune, Susan K., Burckart, Gilbert J., Zineh, Issam
Publicado no Clin Pharmacol Ther (2018)

Primary Endpoints in Pediatric Efficacy Trials Submitted to the US FDA

Por Green, Dionna J., Burnham, Janelle M., Schuette, Paul, Liu, Xiaomei I., Maas, Brian M., Yao, Lynne, McCune, Susan K., Chen, Joseph, van den Anker, John N., Burckart, Gilbert J.
Publicado no J Clin Pharmacol (2018)

Monoclonal Antibodies and Fc‐Fusion Proteins for Pediatric Use: Dosing, Immunogenicity, and Modeling and Simulation in Data Submitted to the US Food and Drug Administration

Por Liu, Xiaomei I., Dallmann, André, Wang, Yow‐Ming, Green, Dionna J., Burnham, Janelle M., Chiang, Beatrice, Wu, Perry, Sheng, Mark, Lu, Kelley, van den Anker, John N., Burckart, Gilbert J.
Publicado no J Clin Pharmacol (2019)

Research Gaps in Primary Pediatric Hypertension

Por Taylor-Zapata, Perdita, Baker-Smith, Carissa M., Burckart, Gilbert, Daniels, Stephen R., Flynn, Joseph T., Giacoia, George, Green, Dionna, Kelly, Aaron S., Khurana, Mona, Li, Jennifer S., Pratt, Charlotte, Urbina, Elaine M., Zajicek, Anne
Publicado no Pediatrics (2019)

Exposure Matching for Extrapolation of Efficacy in Pediatric Drug Development

Por Mulugeta, Yeruk, Barrett, Jeffrey S., Nelson, Robert, Eshete, Abel Tilahun, Mushtaq, Alvina, Yao, Lynne, Glasgow, Nicole, Mulberg, Andrew E., Gonzalez, Daniel, Green, Dionna, Florian, Jeffry, Krudys, Kevin, Seo, Shirley, Kim, Insook, Chilukuri, Dakshina, Burckart, Gilbert J.
Publicado no J Clin Pharmacol (2016)

Association Between Thiopurine S-Methyltransferase (TPMT) Genetic Variants and Infection in Pediatric Heart Transplant Recipients Treated With Azathioprine: A Multi-Institutional A...

Por Green, Dionna J., Duong, Son Q., Burckart, Gilbert J., Sissung, Tristan, Price, Douglas K., Figg, William D., Brooks, Maria M., Chinnock, Richard, Canter, Charles, Addonizio, Linda, Bernstein, Daniel, Naftel, David C., Zeevi, Adriana, Kirklin, James K., Webber, Steven A., Feingold, Brian
Publicado no J Pediatr Pharmacol Ther (2018)

Multi-institutional Study of Outcomes After Pediatric Heart Transplantation: Candidate Gene Polymorphism Analysis of ABCC2

Por Burckart, Gilbert J., Figg, William D., Brooks, Maria M., Green, Dionna J., Troutman, Sarah M., Ferrell, Robert, Chinnock, Richard, Canter, Charles, Addonizio, Linda, Bernstein, Daniel, Kirklin, James K., Naftel, David, Price, Douglas K., Sissung, Tristan M., Girnita, Diana M., Zeevi, Adriana, Webber, Steven A.
Publicado em 2014