British journal of clinical pharmacology
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Br J Clin Pharmacol · Oct 2009
Randomized Controlled Trial Comparative StudyA comparison of two formulations of intradermal capsaicin as models of neuropathic pain in healthy volunteers.
To compare the dose-response relationships of two formulations [Tween- or hydroxypropyl-b-cyclodextrin (HP-b-CD)-based] of intradermal capsaicin in healthy volunteers and to assess the effect of potential covariates of response. One, 10, 30 and 100 microg in 10 ml were compared for the outcomes of flare, spontaneous pain, mechanical allodynia and hyperalgesia in eight healthy men and eight healthy women. ⋯ The formulations are comparable over the dose range 1-30 microg. The significantly lower pain response at the 100 microg dose in the Tween compared with the HP-beta-CD formulation is likely to be due to limitations in solubility at the 100 microg level. Given the greater ease of formulation and the superior dose-response relationship, the HP-beta-CD formulation is preferable for use in the model in future studies.
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Br J Clin Pharmacol · Oct 2009
Multicenter StudySelf-medication among children and adolescents in Germany: results of the National Health Survey for Children and Adolescents (KiGGS).
Despite the widespread use of self-medication among the child population and the potential harm it can do, up-to-date epidemiological data on self-medication are sparse worldwide. The aim was to investigate the prevalence and correlates of self-medication use among non-institutionalized children in Germany, focusing on the paediatric self-medications that are most frequently used. ⋯ Self-medication use is highly prevalent in Germany, particularly among children and adolescents from families with a higher socioeconomic status. Self-medication in younger children using such drugs as CCMs and aspirin suggested inappropriate drug use and potential risks. This should be closely monitored and warrants an education programme for parents in Germany.
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Br J Clin Pharmacol · Oct 2009
Progenitors in motion: mechanisms of mobilization of endothelial progenitor cells.
Endothelial progenitor cells are a population of bone marrow-derived mononuclear cells thought to engage in endothelial repair and hence are considered potential therapeutic agents in many pathological conditions. The mechanism of their exit from the bone marrow to the circulation and damaged tissues, termed mobilization, has not been fully elucidated. Despite this, several pharmacological interventions have been shown to influence mobilization of these specialized cells. Here we review the current understanding of their mobilization.
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Br J Clin Pharmacol · Oct 2009
Proposals for model-based paediatric medicinal development within the current European Union regulatory framework.
The new paediatric European Union (EU) regulation and the consequent demand for paediatric studies on one hand and the ethical need for minimizing the burden of studies in children on the other hand necessitate optimal techniques in the assessment of safety/efficacy and use of drugs in children. Modelling and simulation (M&S) is one way to circumvent some difficulties in developing medicinal products in children. M&S allows the quantitative use of sparse sampling, characterization and prediction of pharmacokinetics/pharmacodynamics (PK/PD), extrapolation from adults to children, interpolation between paediatric age subsets, optimal use of scientific literature and in vitro/preclinical data. ⋯ The article presents the personal views of the authors on the issues presented and discussed in the workshop. We attempt to identify the regulatory framework for the use of M&S in paediatric medicinal development and to make proposals for model-based paediatric medicinal development. The objective is to open the discussion between industry, academia, paediatricians and regulators on the optimal use of M&S in paediatric medicinal development.