Search Results - "BURCKART, G. J"

Failed Pediatric Drug Development Trials by Momper, JD, Mulugeta, Y, Burckart, GJ

“…Pediatric product development initiatives have stimulated the development of therapies for children, resulting in improved product labeling, increased…”
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Regulatory Experience With Physiologically Based Pharmacokinetic Modeling for Pediatric Drug Trials by Leong, R, Vieira, M L T, Zhao, P, Mulugeta, Y, Lee, C S, Huang, S-M, Burckart, G J

“…Physiologically based pharmacokinetic (PBPK) approaches that incorporate the developmental physiology and ontogeny of cytochrome P450 (CYP) enzymes may have…”
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Assessment of the Impact of Renal Impairment on Systemic Exposure of New Molecular Entities: Evaluation of Recent New Drug Applications by Zhang, Y, Zhang, L, Abraham, S, Apparaju, S, Wu, T‐C, Strong, JM, Xiao, S, Atkinson, AJ, Thummel, KE, Leeder, JS, Lee, C, Burckart, GJ, Lesko, LJ, Huang, S‐M

“…The US Food and Drug Administration (FDA) is currently developing a guidance for industry to replace a previous guidance, “Pharmacokinetics in Patients With…”
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Pharmacogenomic information in FDA-approved drug labels: Application to pediatric patients by Green, DJ, Mummaneni, P, Kim, IW, Oh, JM, Pacanowski, M, Burckart, GJ

“…Pharmacogenomic (PGx) information is increasingly being incorporated into US Food and Drug Administration‐approved drug labels. We reviewed the data source…”
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Evaluation of the Safety of Drugs and Biological Products Used During Lactation: Workshop Summary by Wang, J, Johnson, T, Sahin, L, Tassinari, MS, Anderson, PO, Baker, TE, Bucci‐Rechtweg, C, Burckart, GJ, Chambers, CD, Hale, TW, Johnson‐Lyles, D, Nelson, RM, Nguyen, C, Pica‐Branco, D, Ren, Z, Sachs, H, Sauberan, J, Zajicek, A, Ito, S, Yao, LP

“…This report serves as a summary of a 2‐day public workshop sponsored by the US Food and Drug Administration (FDA) to discuss the safety of drugs and biological…”
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IMPDH1 Gene Polymorphisms and Association With Acute Rejection in Renal Transplant Patients by Wang, J, Yang, JW, Zeevi, A, Webber, SA, Girnita, DM, Selby, R, Fu, J, Shah, T, Pravica, V, Hutchinson, IV, Burckart, GJ

“…Inosine 5′‐monophosphate dehydrogenase 1 (IMPDH1) catalyzes the rate‐limiting step of the de novo pathway for purine synthesis and is a major target of the…”
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A Survey of Neonatal Pharmacokinetic and Pharmacodynamic Studies in Pediatric Drug Development by Wang, J, Avant, D, Green, D, Seo, S, Fisher, J, Mulberg, AE, McCune, SK, Burckart, GJ

“…Conducting clinical trials in neonates is challenging, and knowledge gaps in neonatal clinical pharmacology exist. We surveyed the US Food and Drug…”
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P-glycoprotein and Drug Therapy in Organ Transplantation by Lo, Agnes, Burckart, Gilbert J.

“…The role of multidrug resistance and P‐glycoprotein (P‐gp) in the development of drug‐resistant tumor cells has been extensively studied. As more knowledge on…”
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Nuclear Factor Kappa B: Important Transcription Factor and Therapeutic Target by Lee, Jang-Ik, Burckart, Gilbert J.

“…Nuclear factor kappa B (NF‐κB) is an ubiquitous rapid response transcription factor in cells involved in immune and inflammatory reactions, and exerts its…”
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Preservation of post-transplant lung function with aerosol cyclosporin by Corcoran, T.E, Smaldone, G.C, Dauber, J.H, Smith, D.A, McCurry, K.R, Burckart, G.J, Zeevi, A, Griffith, B.P, Iacono, A.T

“…Post-lung transplant use of aerosol cyclosporin (ACsA) is considered by examining the relationship between deposited aerosol dose and effect. In a sub-study of…”
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The impact of pharmacogenomic factors on steroid dependency in pediatric heart transplant patients using logistic regression analysis by Zheng, H. X., Webber, S. A., Zeevi, A., Schuetz, E., Zhang, J., Lamba, J., Boyle, G. J., Wilson, J. W., Burckart, G. J.

“…:  Many pharmacogenomic predictors of drug response are now available, and include both drug metabolism‐disposition factors and drug targets. Information on…”
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The Influence of Race and Common Genetic Variations on Outcomes After Pediatric Heart Transplantation by Green, D. J., Brooks, M. M., Burckart, G. J., Chinnock, R. E., Canter, C., Addonizio, L. J., Bernstein, D., Kirklin, J. K., Naftel, D. C., Girnita, D. M., Zeevi, A., Webber, S. A.

“…Significant racial disparity remains in the incidence of unfavorable outcomes following heart transplantation. We sought to determine which pediatric…”
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Cyclosporine A inhibits the expression of costimulatory molecules on in vitro-generated dendritic cells: Association with reduced nuclear translocation of nuclear factor kappa B by LEE, J.-I, GANSTER, R. W, GELLER, D. A, BURCKART, G. J, THOMSON, A. W, LU, L

“…The maturation of dendritic cells (DC) is influenced by various factors, in particular cytokine-mediated signaling events. These include modulation of the…”
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Pediatric Dose Selection by Abernethy, D R, Burckart, G J

“…Selection of a drug dose in pediatrics is generally based on no or incomplete pharmacokinetic data. Traditionally, allometric, or scaling, techniques have been…”
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Tacrolimus: a new immunosuppressive agent by Kelly, P A, Burckart, G J, Venkataramanan, R

“…The mechanism of action, pharmacokinetics, drug interactions, clinical efficacy, and adverse effects of tacrolimus, a newly approved immunosuppressant drug for…”
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Species differences in the hepatic and intestinal metabolism of cyclosporine by WHALEN, R. D., TATA§, P. N. V., BURCKART†, G. J., VENKATARAMAN, R.

“…1. Cyclosporin A (cyclosporine, CSA) is an immunosuppressive drug with a narrow therapeutic index. In the present study the metabolism of CSA was investigated…”
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A comparison of ganciclovir and acyclovir to prevent cytomegalovirus after lung transplantation by Duncan, S R, Grgurich, W F, Iacono, A T, Burckart, G J, Yousem, S A, Paradis, I L, Williams, P A, Johnson, B A, Griffith, B P

“…In an attempt to modify the sequelae of cytomegalovirus (CMV) infections after lung transplantation, 25 allograft recipients were randomized to either…”
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The impact of pharmacogenomic factors on acute persistent rejection in adult lung transplant patients by Zheng, H.X., Zeevi, A., McCurry, K., Schuetz, E., Webber, S., Ristich, J., Zhang, J., Iacono, A., Dauber, J., McDade, K., Zaldonis, D., Lamba, J., Burckart, G.J.

“…Persistent rejection in the face of treatment and multiple episodes of rejection are associated with the development of chronic rejection and graft loss in…”
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Aerosolized cyclosporine in lung recipients with refractory chronic rejection by Iacono, A T, Keenan, R J, Duncan, S R, Smaldone, G C, Dauber, J H, Paradis, I L, Ohori, N P, Grgurich, W F, Burckart, G J, Zeevi, A, Delgado, E, O'Riordan, T G, Zendarsky, M M, Yousem, S A, Griffith, B P

“…This study evaluated aerosolized cyclosporine as rescue therapy for lung transplant recipients with unremitting chronic rejection. Nine patients with…”
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Dose-related reversal of acute lung rejection by aerosolized cyclosporine by Iacono, A T, Smaldone, G C, Keenan, R J, Diot, P, Dauber, J H, Zeevi, A, Burckart, G J, Griffith, B P

“…This study evaluated the effectiveness of aerosolized cyclosporine as rescue therapy for refractory acute rejection in lung-transplant patients that is…”
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