Regulatory Considerations for the Mother, Fetus and Neonate in Fetal Pharmacology Modeling

por Green, Dionna J., Park, Kyunghun, Bhatt-Mehta, Varsha, Snyder, Donna, Burckart, Gilbert J.
Publicado 2021

Inclusion of Adolescents in Adult Clinical Trials: Report of the Institute for Advanced Clinical Trials for Children’s Pediatric Innovation Research Forum

por Noel, Gary J., Nelson, Robert M., Bucci-Rechtweg, Christina, Portman, Ronald, Miller, Thomas, Green, Dionna J., Snyder, Donna, Moreno, Carmen, Hovinga, Collin, Connor, Edward
Publicado 2021

Mechanistic Modeling of Placental Drug Transfer in Humans: How Do Differences in Maternal/Fetal Fraction of Unbound Drug and Placental Influx/Efflux Transfer Rates Affect Fetal Pha...

por Liu, Xiaomei I., Green, Dionna J., van den Anker, John N., Rakhmanina, Natella Y., Ahmadzia, Homa K., Momper, Jeremiah D., Park, Kyunghun, Burckart, Gilbert J., Dallmann, André
Publicado 2021

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 2019