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Your search keyword '"Mondick, John T."' showing total 26 results
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26 results on '"Mondick, John T."'

4. Immunogenicity of cipaglucosidase alfa/miglustat versus alglucosidase alfa/placebo in late-onset Pompe disease (LOPD): A phase III, randomized study (PROPEL)

Author

Chien, Yin-Hsiu, primary, Benjamin, Elfrida, additional, Schoser, Benedikt, additional, Kishnani, Priya, additional, Mozaffar, Tahseen, additional, Díaz-Manera, Jordi, additional, Johnson, Franklin, additional, Das, Sheela Sitaraman, additional, Nair, Anju, additional, Williams, Hadis, additional, Anderson, Eric, additional, Mondick, John T., additional, and Sileno, Anthony, additional

Published
2022
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8. Population Pharmacokinetic Investigation of Actinomycin-D in Children and Young Adults

Author

Mondick, John T., Gibiansky, Leonid, Gastonguay, Marc R., Skolnik, Jeffrey M., Cole, Michael, Veal, Gareth J., Boddy, Alan V., Adamson, Peter C., and Barrett, Jeffrey S.

Subjects
Pharmacokinetics -- Research, Dactinomycin -- Dosage and administration -- Research, Health, Research, Dosage and administration
Abstract

Keywords: Actinomycin-D; pharmacokinetics; pediatrics 35 Quantitative Clinical PharmacologyPopulation Pharmacokinetic Investigation of Actinomycin-D in Children and Young Adults SAGE Publications, Inc.200810.1177/0091270007310383 John T.Mondick PhD Division of Clinical Pharmacology and Therapeutics, The [...]

Published
2008
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9. An informatics approach to assess pediatric pharmacotherapy: design and implementation of a hospital drug utilization system

Author

Zuppa, Athena, Vijayakumar, Sundararajan, Jayaraman, Bhuvana, Patel, Dimple, Narayan, Mahesh, Vijayakumar, Kalpana, Mondick, John T., and Barrett, Jeffrey S.

Subjects
Children -- Diseases, Medical informatics -- Usage -- Research, Drug therapy -- Usage -- Research, Health, Drug therapy, Usage, Research
Abstract

Drug utilization in the inpatient setting can provide a mechanism to assess drug prescribing trends, efficiency, and cost-effectiveness of hospital formularies and examine subpopulations for which prescribing habits may be [...]

Published
2007

10. Drug utilization in the pediatric intensive care unit: monitoring prescribing trends and establishing prioritization of pharmacotherapeutic evaluation of critically Ill children

Author

Zuppa, Athena F., Adamson, Peter C., Mondick, John T., Davis, Lauren A., Maka, Deborah A., Narayan, Mahesh, Nicholson, Charles, Patel, Dimple, Collison, Kathryn R., and Barrett, Jeffrey S.

Subjects
Critically ill children -- Drug therapy -- Research, Pediatric pharmacology -- Research, Pediatric intensive care -- Management -- Research, Health, Company business management, Management, Drug therapy, Research
Abstract

The primary objective of this study was to characterize the drug exposure for children hospitalized in the authors' institution's pediatric intensive care unit for the year 2002. Secondary objectives included [...]

Published
2005

13. Integration of modeling and simulation into hospital-based decision support systems guiding pediatric pharmacotherapy

Author

Vijayakumar Kalpana, Narayan Mahesh, Mondick John T, Barrett Jeffrey S, and Vijayakumar Sundararajan

Subjects
Computer applications to medicine. Medical informatics, R858-859.7
Abstract

Abstract Background Decision analysis in hospital-based settings is becoming more common place. The application of modeling and simulation approaches has likewise become more prevalent in order to support decision analytics. With respect to clinical decision making at the level of the patient, modeling and simulation approaches have been used to study and forecast treatment options, examine and rate caregiver performance and assign resources (staffing, beds, patient throughput). There us a great need to facilitate pharmacotherapeutic decision making in pediatrics given the often limited data available to guide dosing and manage patient response. We have employed nonlinear mixed effect models and Bayesian forecasting algorithms coupled with data summary and visualization tools to create drug-specific decision support systems that utilize individualized patient data from our electronic medical records systems. Methods Pharmacokinetic and pharmacodynamic nonlinear mixed-effect models of specific drugs are generated based on historical data in relevant pediatric populations or from adults when no pediatric data is available. These models are re-executed with individual patient data allowing for patient-specific guidance via a Bayesian forecasting approach. The models are called and executed in an interactive manner through our web-based dashboard environment which interfaces to the hospital's electronic medical records system. Results The methotrexate dashboard utilizes a two-compartment, population-based, PK mixed-effect model to project patient response to specific dosing events. Projected plasma concentrations are viewable against protocol-specific nomograms to provide dosing guidance for potential rescue therapy with leucovorin. These data are also viewable against common biomarkers used to assess patient safety (e.g., vital signs and plasma creatinine levels). As additional data become available via therapeutic drug monitoring, the model is re-executed and projections are revised. Conclusion The management of pediatric pharmacotherapy can be greatly enhanced via the immediate feedback provided by decision analytics which incorporate the current, best-available knowledge pertaining to dose-exposure and exposure-response relationships, especially for narrow therapeutic agents that are difficult to manage.

Published
2008
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23. Population Pharmacokinetics of Milrinone in Neonates with Hypoplastic Left Heart Syndrome Undergoing Stage I Reconstruction

Author

Zuppa, Athena F., primary, Nicolson, Susan C., additional, Adamson, Peter C., additional, Wernovsky, Gil, additional, Mondick, John T., additional, Burnham, Nancy, additional, Hoffman, Timothy M., additional, Gaynor, J William, additional, Davis, Lauren A., additional, Greeley, William J., additional, Spray, Thomas L., additional, and Barrett, Jeffrey S., additional

Published
2006
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24. Safety, Tolerability, Pharmacokinetics, and Time Course of Pharmacologic Response of the Active Metabolite of Roxifiban, XV459, a Glycoprotein IIb/IIIa Antagonist, following Oral Administration in Healthy Volunteers

Author

Pieniaszek, Henry J., primary, Sy, Sherwin K. B., additional, Ebling, William, additional, Fossler, Michael J., additional, Cain, Valerie A., additional, Mondick, John T., additional, Ma, Su, additional, and Kornhauser, David M., additional

Published
2002
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25. Plasma topiramate concentrations resulting from doses associated with neuroprotection against white matter injury and stroke in two strains of rat pups

Author

Clark, Annie M., Mondick, John T., Cloyd, James C., Zuppa, Athena F., Raol, Yogendra H., and Clancy, Robert R.

Abstract

Background:Cerebral white matter (WM) injury and stroke are common neuropathological injuries in newborns with congenital heart defects (CHDs) requiring surgery. Previous investigations in Long Evans rat pups subjected to hypoxia–ischemia found that intraperitoneal (i.p.) topiramate (TPM) at 30?mg/kg, but not 50?mg/kg, conferred neuroprotection. In Sprague-Dawley pups, a dose of 30?mg/kg protected against stroke. Concentrations associated with neuroprotective doses were not measured. The aims of this investigation were to determine concentrations associated with neuroprotective doses and to investigate the pharmacokinetics (PK) of i.p. TPM.Methods:Concentration–time data following administration of 30 and 50?mg/kg doses were analyzed using nonlinear mixed–effect modeling.Results:Mean predicted steady-state maximum and average concentrations following 30?mg/kg TPM were 31.3 and 16.8?µg/ml in Long Evans and 39.9 and 24.4?µg/ml in Sprague-Dawley pups. Mean predicted steady-state maximum and average concentrations following 50?mg/kg TPM were 52.1 and 28.1?µg/ml in Long Evans and 66.5 and 40.6?µg/ml in Sprague-Dawley pups. The apparent clearance (CL/F) and apparent volume of distribution (V/F) were 0.0470?ml/min and 22.2?ml, respectively, for Long Evans and 0.0325?ml/min and 19.7?ml, respectively, for Sprague-Dawley pups.Conclusion:TPM concentrations associated with neuroprotective doses were determined. Body size and strain were significant covariates on CL/F and V/F. Results provide targets for future neuroprotection studies.

Published
2013
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26. Population Pharmacokinetic Investigation of Actinomycin-D in Children and Young Adults

Author

Leonid Gibiansky, Alan V. Boddy, Gareth J. Veal, Peter C. Adamson, Jeffrey M. Skolnik, Marc R. Gastonguay, John T. Mondick, Michael Cole, Jeffrey S. Barrett, Mondick, John T, Gibiansky, Leonid, Gastonguay, Marc R, Skolnik, Jeffrey M, Cole, Michael, Veal, Gareth J, Boddy, Alan V, Adamson, Peter C, and Barrett, Jeffrey S

Subjects
Adult, Male, Oncology, medicine.medical_specialty, Adolescent, Databases, Factual, pediatrics, Metabolic Clearance Rate, Population, Pharmacology, Models, Biological, Wilms Tumor, Statistics, Nonparametric, Pharmacokinetics, Tandem Mass Spectrometry, actinomycin-D, Internal medicine, Rhabdomyosarcoma, Covariate, Confidence Intervals, Humans, Medicine, Pharmacology (medical), Pharmacology & Pharmacy, Young adult, Child, Infusions, Intravenous, education, Prospective cohort study, Clinical Trials as Topic, education.field_of_study, Antibiotics, Antineoplastic, business.industry, Infant, Wilms' tumor, Hospitals, Pediatric, medicine.disease, NONMEM, Clinical trial, Child, Preschool, Injections, Intravenous, Dactinomycin, Female, business, pharmacokinetics, Algorithms, Chromatography, Liquid
Abstract

Actinomycin-D is an antineoplastic agent that inhibits RNA synthesis by binding to guanine residues and inhibiting DNA-dependent RNA polymerase. Although actinomycin-D has been used to treat rhabdomyosarcoma and Wilms tumor for more than 40 years, the dose/exposure relationship is not well characterized. The objective of this study was to develop an initial population pharmacokinetic model to describe actinomycin-D disposition in children and young adults from which a prospective study could be designed. A total of 165 actinomycin-D plasma concentration measurements from 33 patients, aged 1.6 to 20.3 years, were used for the analysis. The data were analyzed using nonlinear mixed-effects modeling with the NONMEM software system. Age, weight, and gender were examined as covariates for the ability to explain interindividual variability in actinomycin-D pharmacokinetics. The final model was qualified via predictive check and non-parametric bootstrap procedures. A 3-compartment model with first-order elimination was chosen as the structural model. Allometric expressions incorporating weight were used to describe the effects of body size on actinomycin-D pharmacokinetics. Age and gender had no discernible effects on actinomycin-D pharmacokinetics in the population studied. The predictive check showed that the developed model was able to simulate data in close agreement with the actual study observations. The availability of an initial population pharmacokinetic model to describe actinomycin-D pharmacokinetics will facilitate the development of a large-scale clinical trial to study the actinomycin-D dose/exposure relationship in pediatric patients with rhabdomyosarcoma and Wilms tumor. The covariate analysis described by the current data set suggests that indices of body size captured via allometric expressions improve the partition of variation in actinomycin-D pharmacokinetics from this pilot data set. Relationships between pharmacokinetics and toxicity will be examined in future prospective studies in which children less than 1 year old will be enrolled. Refereed/Peer-reviewed

Published
2008

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