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- Volume 21, Issue 39, 2015
Current Pharmaceutical Design - Volume 21, Issue 39, 2015
Volume 21, Issue 39, 2015
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Ethical Considerations in Conducting Pediatric and Neonatal Research in Clinical Pharmacology
Authors: Michelle Roth-Cline and Robert M. NelsonThe critical need for pediatric research on drugs and biological products underscores the responsibility to ensure that children are enrolled in clinical research that is both scientifically necessary and ethically sound. In this chapter, we review key ethical considerations concerning the participation of children. We review a basic ethical framework to guide pediatric research, and suggest how this framework might be op Read More
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Functional Biomarkers: an Approach to Bridge Pharmacokinetics and Pharmacodynamics in Pediatric Clinical Trials
Authors: Gregory L. Kearns and Michael ArtmanOver the past 30 years, much has been learned about the impact of development on drug disposition (i.e., pharmacokinetics). This is not true concerning drug action (i.e., pharmacodynamics). As a consequence, in clinical therapeutics and the drug development process, assumptions are often times made that a specific systemic drug exposure that is associated with desired drug action in adults will produce the same resp Read More
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New Ways of Detecting ADRs in Neonates and Children
Authors: Ricardo Jimenez, Anne Smith and Bruce CarletonSevere adverse drug reactions (ADRs) cause 5-7% of all hospital admissions, an estimated 2,000,000 severe reactions, and over 100,000 deaths each year in the USA. A recent systematic review indicated that the overall incidence of ADRs was 11% in hospitalized children and 1% in outpatients. Detecting ADRs in neonates and children is challenging, particularly because there are fewer clinical trials involving children Read More
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Clinical Pharmacology of Frequently Used Intravenous Drugs During Bariatric Surgery in Adolescents
Authors: Janelle D. Vaughns, Victoria C. Ziesenitz and John N. van den AnkerObesity represents one of the most important public health issues according to the World Health Organization. Additionally, in a recent National Health and Nutrition Survey of 2011-2012, approximately 17 % of children and adolescents in the United States were considered obese. The obesity rate is higher within the adolescent age group as compared to preschool children. Childhood obesity is particularly problematic, because Read More
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Pharmacotherapy of Sickle Cell Disease in Children
Authors: Kathleen A. Neville and Julie A. PanepintoSickle cell disease (SCD) is a potentially devastating and life threatening condition that is caused by an autosomal recessive inherited hemoglobinopathy which results in vaso-occlusive phenomena and hemolysis. The severity of this disorder is widely variable, but overall mortality is increased and life expectancy decreased when compared to the general population. Care of patients with sickle cell disease is largely su Read More
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Availability of Oral Formulations Labeled for Use in Young Children in Serbia, Germany and the USA
Authors: Milica Bajcetic, Gregory L. Kearns, Ida Jovanovic, Milan Brajovic and John N. van den AnkerBackground: The paucity of marketed drug products that have been adequately studied in infants and children and subsequently, licensed (or labeled) for pediatric use has caused abundant use of off-label and unauthorized products in this patient population. In those instances where insufficient pharmacologic or therapeutic information exists for children, the potential for off-label use of medicines to result in therapeu Read More
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Neonatal Formulations: The Need for a Tailored, Knowledge Driven Approach
Authors: Karel Allegaert, Katrien Cosaert and John N. van den AnkerTo attain effective and safe pharmacotherapy in neonates, caregivers have to consider both the clinical characteristics of the newborn and the pharmacokinetic estimates of a given compound during prescription and administration. Overall, clearance in neonates is low when compared to other pediatric subpopulations. Despite this overall low clearance, there is already extensive between individual variability in clearance i Read More
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Why are Excipients Important to Neonates?
Authors: Mark A. Turner and Utpal ShahNeonates are given many medicines. A significant proportion of these medicines contain excipients. Excipients are used to facilitate the manufacture and use of medicines. Without excipients, it would not be feasible to formulate some drugs into appropriate medicinal products. For others the removal of excipients would reduce the shelf life and make them uneconomic to produce or too expensive for users to purch Read More
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Development of a Physiologically-Based Pharmacokinetic Model for Preterm Neonates: Evaluation with In Vivo Data
Among pediatric patients, preterm neonates and newborns are the most vulnerable subpopulation. Rapid developmental changes of physiological factors affecting the pharmacokinetics of drug substances in newborns require extreme care in dose and dose regimen decisions. These decisions could be supported by in silico methods such as physiologically-based pharmacokinetic (PBPK) modeling. In a comprehensive literature s Read More
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Dosing Guidelines of Aminoglycosides in Neonates: A Balance Between Physiology and Feasibility
Authors: Karel Allegaert, Veerle Cossey and John N. van den AnkerOnce daily dosing of aminoglycosides has been introduced and validated in non-neonatal patient cohorts. This is because aminoglycosides display peak concentration dependent bacterial killing, have a postantibiotic effect and adaptive resistance. In addition, this strategy reduces toxicity. Although aminoglycosides are also frequently administered to neonates, there is still debate about how to integrate and extrapolate the Read More
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The Impact of Hypothermia on the Pharmacokinetics of Drugs Used in Neonates and Young Infants
Authors: P. Pokorna, E.D. Wildschut, V. Vobruba, John N. van den Anker and D. TibboelTherapeutic hypothermia (HT) is frequently used in neonates with hypoxic-ischemic encephalopathy and young infants during cardiopulmonary bypass (CPB). Hypothermia and CPB result in physiological changes contributing to pharmacokinetic (PK) and pharmacodynamic (PD) changes. Changes in the absorption, the volume of distribution (Vd) and the total body clearance (CL) of drugs used during hypothermia and CPB Read More
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The Potential Effect of Fluorinated Compounds in the Treatment of Alzheimer’s Disease
Authors: Barbara Gomes, Joana A. Loureiro, Manuel A.N. Coelho and Maria do Carmo PereiraDrug development for neurodegenerative diseases such as Alzheimer’s disease (AD) is a challenge, not only due to the cellular molecular mechanisms involved, but also because of the inherent difficulty of most molecules to cross the blood-brain-barrier (BBB). A promising approach to overcome these drawbacks is developing fluorinated molecules and supramolecular assemblies. This review focuses on the therapeutic Read More
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Half-Life of Sulfonylureas in HNF1A and HNF4A Human MODY Patients is not Prolonged as Suggested by the Mouse Hnf1a-/- Model
Objectives: Sulfonylurea derivatives are widely used for clinical treatment of human subjects with Maturity Onset Diabetes of the Young (MODY) caused by mutations in HNF-1α or HNF-4α despite the mechanism leading to their hypersensitivity is incompletely understood. In Hnf1a-/- mice, serum concentrations and half-life of sulfonylurea derivatives are strongly increased. We thus hypothesized that reduced sulfonylurea d Read More
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Volumes & issues
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Volume 31 (2025)
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Volume 30 (2024)
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Volume 29 (2023)
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Volume 28 (2022)
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Volume 27 (2021)
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Volume 26 (2020)
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Volume 25 (2019)
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Volume 24 (2018)
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Volume 23 (2017)
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Volume 22 (2016)
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Volume 21 (2015)
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Volume 20 (2014)
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Volume 19 (2013)
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Volume 18 (2012)
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Volume 17 (2011)
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Volume 16 (2010)
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Volume 15 (2009)
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Volume 14 (2008)
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Volume 13 (2007)
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Volume 12 (2006)
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Volume 11 (2005)
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Volume 10 (2004)
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Volume 9 (2003)
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Volume 8 (2002)
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Volume 7 (2001)
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Volume 6 (2000)
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