Search Results - "Green, Dionna J"

Promoting Clinical Trial Diversity: A Highlight of Select US FDA Initiatives by Ramamoorthy, Anuradha, Araojo, Richardae, Vasisht, Kaveeta P., Fienkeng, Mathilda, Green, Dionna J., Madabushi, Rajanikanth

“…Although the population in the United States is diverse, there are disparities in healthcare outcomes in some populations, for example, based on…”
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Physiologically Based Pharmacokinetic Models to Predict Maternal Pharmacokinetics and Fetal Exposure to Emtricitabine and Acyclovir by Liu, Xiaomei I., Momper, Jeremiah D., Rakhmanina, Natella, den Anker, John N., Green, Dionna J., Burckart, Gilbert J., Best, Brookie M., Mirochnick, Mark, Capparelli, Edmund V., Dallmann, André

“…Pregnancy is associated with physiological changes that may impact drug pharmacokinetics (PK). The goals of this study were to build maternal‐fetal…”
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Regulatory Considerations for the Mother, Fetus and Neonate in Fetal Pharmacology Modeling by Green, Dionna J., Park, Kyunghun, Bhatt-Mehta, Varsha, Snyder, Donna, Burckart, Gilbert J.

“…The regulatory framework for considering the fetal effects of new drugs is limited. This is partially due to the fact that pediatric regulations (21 CFR…”
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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 Pharmacokinetics? by 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

“…Background: While physiologically based pharmacokinetic (PBPK) models generally predict pharmacokinetics in pregnant women successfully, the confidence in…”
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Pediatric Drug Development: Outlook for Science‐Based Innovation by Green, Dionna J., Zineh, Issam, Burckart, Gilbert J.

“…There has been significant progress in pediatric drug development during the past 15 years. Results from 1,200 pediatric studies have been submitted to the US…”
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Pharmacological Arguments Against the Use of Ketamine in Nonmedical Settings by Green, Dionna J., Masters, Joanna C.

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Application of Quantitative Systems Pharmacology to Pediatric Drug Safety Assessment by Samuels, Sherbet, Bai, Jane P. F., Green, Dionna J., Abulwerdi, Gelareh, Burckart, Gilbert J.

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Pediatric Drug Development Studies for Familial Hypercholesterolemia Submitted to the US Food and Drug Administration Between 2007 and 2020 by Park, Kyunghun, Vishnevetskaya, Kristina, Vaidyanathan, Jayabharathi, Burckart, Gilbert J., Green, Dionna J.

“…Familial hypercholesterolemia (FH) is an autosomal dominant genetic disorder of lipoprotein metabolism that leads to an increased risk of developing…”
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Labetalol Dosing in Pregnancy: PBPK/PD and CYP2C19 Polymorphisms by Liu, Xiaomei I., Green, Dionna J., van den Anker, John, Calderon, Joaquin, Ahmadzia, Homa, Burckart, Gilbert J., Dallmann, André

“…As detailed information on the pharmacokinetics (PK) of labetalol in pregnant people are lacking, the aims of this study were: (1) to build a physiologically…”
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Development of a Generic Fetal Physiologically Based Pharmacokinetic Model and Prediction of Human Maternal and Fetal Organ Concentrations of Cefuroxime by Liu, Xiaomei I., Green, Dionna J., van den Anker, John, Ahmadzia, Homa K., Burckart, Gilbert J., Dallmann, André

“…Background and Objective Physiologically based pharmacokinetic (PBPK) models for pregnant women have recently been successfully used to predict maternal and…”
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Pediatric and Adult Placebo Response Rates in Placebo‐Controlled Clinical Trials Submitted to the US Food and Drug Administration 2012–2020 by Park, Kyunghun, Tran, Ngan K., Momper, Jeremiah D., Green, Dionna J., Burckart, Gilbert J.

“…The use of placebo concurrent control (placebo‐controlled) is the most rigorous method of evaluating the safety and efficacy of investigational treatments…”
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Pediatric Efficacy Extrapolation in Drug Development Submitted to the US Food and Drug Administration 2015–2020 by Samuels, Sherbet, Park, Kyunghun, Bhatt‐Mehta, Varsha, Sun, Haihao, Mulugeta, Yeruk, Yao, Lynne, Green, Dionna J., Burckart, Gilbert J.

“…Pediatric extrapolation plays a key role in the availability of reliable pediatric use information in approved drug labeling. This review examined the use of…”
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Drug Safety in Labeling for Pediatric Drug Development and Dose Selection in Submissions to the US Food and Drug Administration by Kim, Clara, Park, Kyunghun, McMahon, Ann W., Green, Francis G., Green, Dionna J., Burckart, Gilbert J.

“…Pediatric safety evaluations are an essential part of a pediatric drug development program. Communication of the results of these safety evaluations is…”
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A Comparison of Pediatric and Adult Safety Studies for Antipsychotic and Antidepressant Drugs Submitted to the United States Food and Drug Administration by Liu, Xiaomei I., Schuette, Paul, Burckart, Gilbert J., Green, Dionna J., La, Julie, Burnham, Janelle M., Rakhmanina, Natella, Robb, Adelaide, Huang, Shiew Mei, van den Anker, John N.

“…To examine the differences in the adverse drug reaction (ADR) profile of antipsychotic and antidepressant agents between pediatric and adult patients in…”
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Inclusion of Infants and Neonates in Pediatric Orphan Product Approvals by Park, Kyunghun, Virparia, Riddhi, Green, Dionna J., Epps, Carla, Wharton, Gerold T., McCune, Susan K., Burckart, Gilbert J.

“…The Orphan Drug Act (ODA) of 1983 was enacted to provide financial incentives to drug sponsors to develop therapies for rare diseases. Although this act…”
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Prediction of Maternal and Fetal Pharmacokinetics of Dolutegravir and Raltegravir Using Physiologically Based Pharmacokinetic Modeling by Liu, Xiaomei I., Momper, Jeremiah D., Rakhmanina, Natella Y., Green, Dionna J., Burckart, Gilbert J., Cressey, Tim R., Mirochnick, Mark, Best, Brookie M., van den Anker, John N., Dallmann, André

“…Background Predicting drug pharmacokinetics in pregnant women including placental drug transfer remains challenging. This study aimed to develop and evaluate…”
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Physiologically Based Pharmacokinetic Modeling Framework to Predict Neonatal Pharmacokinetics of Transplacentally Acquired Emtricitabine, Dolutegravir, and Raltegravir by Liu, Xiaomei I., Momper, Jeremiah D., Rakhmanina, Natella Y., Green, Dionna J., Burckart, Gilbert J., Cressey, Tim R., Mirochnick, Mark, Best, Brookie M., van den Anker, John N., Dallmann, André

“…Background and Objective Little is understood about neonatal pharmacokinetics immediately after delivery and during the first days of life following…”
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Combined Pediatric and Adult Trials Submitted to the US Food and Drug Administration 2012–2018 by Tanaudommongkon, Irin, John Miyagi, Shogo, Green, Dionna J., Burnham, Janelle M., Anker, John N., Park, Kyunghun, Wu, Johanna, McCune, Susan K., Yao, Lynne, Burckart, Gilbert J.

“…Despite legislation incentivizing and requiring drug companies to conduct pediatric clinical trials, there still is a 9‐year delay in drug approval for…”
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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 by Liu, Xiaomei I., Dallmann, André, Wang, Yow‐Ming, Green, Dionna J., Burnham, Janelle M., Chiang, Beatrice, Wu, Perry, Sheng, Mark, Lu, Kelley, Anker, John N., Burckart, Gilbert J.

“…The experience with the use of monoclonal antibodies and Fc‐fusion proteins (mAb/Fc) in the pediatric population is limited. The objective of this study is to…”
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Adolescent dosing and labeling since the Food and Drug Administration Amendments Act of 2007 by Momper, Jeremiah D, Mulugeta, Yeruk, Green, Dionna J, Karesh, Alyson, Krudys, Kevin M, Sachs, Hari C, Yao, Lynn P, Burckart, Gilbert J

“…During pediatric drug development, dedicated pharmacokinetic studies are generally performed in all relevant age groups to support dose selection for…”
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