Zobrazeno 1 - 10
of 43
pro vyhledávání: '"Dionna J Green"'
Autor:
Xiaomei I. Liu, Dionna J. Green, John N. van den Anker, Natella Y. Rakhmanina, Homa K. Ahmadzia, Jeremiah D. Momper, Kyunghun Park, Gilbert J. Burckart, André Dallmann
Publikováno v:
Frontiers in Pediatrics, Vol 9 (2021)
Background: While physiologically based pharmacokinetic (PBPK) models generally predict pharmacokinetics in pregnant women successfully, the confidence in predicting fetal pharmacokinetics is limited because many parameters affecting placental drug t
Externí odkaz:
https://doaj.org/article/f4541b75f8c84cbd94df9dab5d82a079
Publikováno v:
Frontiers in Pediatrics, Vol 9 (2021)
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 subpart D) do not apply to the fetus, and only US Health and Human Service (HHS) regulations appl
Externí odkaz:
https://doaj.org/article/a64124a612a143cabac0ab7f15975980
Autor:
Anuradha, Ramamoorthy, Richardae, Araojo, Kaveeta P, Vasisht, Mathilda, Fienkeng, Dionna J, Green, Rajanikanth, Madabushi
Publikováno v:
Clinical Pharmacology & Therapeutics. 113:528-535
Although the population in the United States is diverse, there are disparities in healthcare outcomes in some populations, for example, based on characteristics such as race, ethnicity, sex, gender, age, socioeconomic status, and geographic location.
Autor:
Dionna J Green, Susan McCune, Amber Ray, Gilbert J. Burckart, Janelle M. Burnham, Shiwei Fang, Lynne Yao
Publikováno v:
Therapeutic Innovation & Regulatory Science. 55:622-630
Corticosteroid use has been associated with hypothalamic–pituitary–adrenal (HPA) axis suppression which can predispose the pediatric patient to multiple immune- and growth-related adverse effects. The objectives of this review were to identify th
Autor:
Jeremiah D. Momper, John N. van den Anker, André Dallmann, Mark Mirochnick, Dionna J Green, Brookie M. Best, Xiaomei I Liu, Tim R. Cressey, Gilbert J. Burckart, Natella Rakhmanina
Publikováno v:
Clin Pharmacokinet
Little is understood about neonatal pharmacokinetics immediately after delivery and during the first days of life following intrauterine exposure to maternal medications. Our objective was to develop and evaluate a novel, physiologically based pharma
Publikováno v:
Therapeutic Innovation & Regulatory Science. 55:282-303
Placebo-controlled trials are the most rigorous method of evaluating the safety and efficacy of investigational treatments, yet the use of a placebo control in pediatric drug development is challenging and potentially controversial. Regulations provi
Autor:
Kyunghun Park, Lynne Yao, Gilbert J. Burckart, Susan McCune, Janelle M. Burnham, John N. van den Anker, Dionna J Green, Shogo John Miyagi, Irin Tanaudommongkon, Johanna Wu
Publikováno v:
Clinical Pharmacology & Therapeutics. 108:1018-1025
Despite legislation incentivizing and requiring drug companies to conduct pediatric clinical trials, there still is a 9-year delay in drug approval for pediatric labeling after the initial adult drug approval. The aim of this study was to review the
Autor:
Issam Zineh, Dionna J. Green, Xinning Yang, Martina D. Sahre, Jeffry Florian, Rajanikanth Madabushi, Anuradha Ramamoorthy, Lauren Milligan, Lei Zhang, Daphney Jean, Kimberly Maxfield, Elimika Pfuma Fletcher
Publikováno v:
Clin Pharmacol Ther
The Guidance and Policy Team (GPT) within the Office of Clinical Pharmacology (OCP) at the US Food and Drug Administration (FDA) was established in 2016 to ensure development and issuance of timely, relevant guidances and policies in the multidiscipl
Publikováno v:
Journal of clinical pharmacologyReferences. 62(8)
The use of placebo concurrent control (placebo-controlled) is the most rigorous method of evaluating the safety and efficacy of investigational treatments. However, the use of a placebo group in pediatric product development can be challenging due to
Autor:
Joanna C. Masters, Dionna J. Green
Publikováno v:
Journal of clinical pharmacologyReferences. 62(1)