International Coherence of Pediatric Drug Labeling for Drug Safety: Comparison of Approved Labels in Korea and the United States

por Song, Yun‐Kyoung, Han, Nayoung, Burckart, Gilbert J., Oh, Jung Mi
Publicado 2019

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

Need for Representation of Pediatric Patients with Obesity in Clinical Trials

por Samuels, Sherbet, Vaidyanathan, Jayabharathi, Fletcher, Elimika Pfuma, Ramamoorthy, Anuradha, Madabushi, Rajanikanth, Burckart, Gilbert J.
Publicado 2023

Pediatric dosing for locally acting drugs in submissions to the U.S. Food and Drug Administration between 2002 and 2020

por Abulwerdi, Gelareh A., Ramamoorthy, Anuradha, Bashaw, Edward, Burckart, Gilbert J., Madabushi, Rajanikanth, Fletcher, Elimika Pfuma
Publicado 2023

Regulation of Pharmacogene Expression by microRNA in The Cancer Genome Atlas (TCGA) Research Network

por Han, Nayoung, Song, Yun-Kyoung, Burckart, Gilbert J., Ji, Eunhee, Kim, In-Wha, Oh, Jung Mi
Publicado 2017

Assessing CYP2C19 Ontogeny in Neonates and Infants Using Physiologically Based Pharmacokinetic Models: Impact of Enzyme Maturation Versus Inhibition

por Duan, Peng, Wu, Fang, Moore, Jason N., Fisher, Jeffrey, Crentsil, Victor, Gonzalez, Daniel, Zhang, Lei, Burckart, Gilbert J., Wang, Jian
Publicado 2018

Development of a Pediatric Relative Bioavailability/Bioequivalence Database and Identification of Putative Risk Factors Associated With Evaluation of Pediatric Oral Products

por Pawar, Gopal, Wu, Fang, Zhao, Liang, Fang, Lanyan, Burckart, Gilbert J., Feng, Kairui, Mousa, Youssef M., Naumann, Franci, Batchelor, Hannah K.
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

Approaches to Dose Finding in Neonates, Illustrating the Variability between Neonatal Drug Development Programs

por Van den Anker, John N., McCune, Susan, Annaert, Pieter, Baer, Gerri R., Mulugeta, Yeruk, Abdelrahman, Ramy, Wu, Kunyi, Krudys, Kevin M., Fisher, Jeffrey, Slikker, William, Chen, Connie, Burckart, Gilbert J., Allegaert, Karel
Publicado 2020