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Risk evaluation of impurities in topical excipients:The acetol case

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Journal of Pharmaceutical Analysis 2014年第5期4卷 303-315页

作者： Jente boonen Lieselotte Veryser Lien Taevernier Nathalie Roche Kathelijne Peremans Christian Burvenich Bart De Spiegeleer Drug Quality and Registration (DruQuaR) Group Faculty of Pharmaceutical SciencesGhent UniversityHarelbekestraat 729000 GhentBelgium Department of Plastic and Reconstructive Surgery University Hospital GhentDe Pintelaan 185B-9000 GhentBelgium Department of Veterinary Medical Imaging and Small Animal Orthopaedics Faculty of Veterinary MedicineGhent UniversitySalisburylaan 133B-9820 MerelbekeBelgium Department of Comparative Physiology and Biometrics Faculty of Veterinary MedicineGhent UniversitySalisburylaan 133B-9820 MerelbekeBelgium

Pharmaceutical excipients for topical use may contain impurities, which are often neglected from a toxicity qualification viewpoint. The possible impurities in the most frequently used topical excipients were evaluated in-silico for their toxicity hazard. Acetol, an impurity likely present in different topical pharmaceutical excipients such as propylene glycol and glycerol, was withheld for the evaluation of its health risk after dermal exposure. 〈br〉 An ex-vivo in-vitro permeation study using human skin in a Franz Diffusion Cell set-up and GC as quantification methodology showed a significant skin penetration with an overall Kp value of 1.82 ？ 10 ？ 3 cm/h. Using these data, limit specifications after application of a dermal pharmaceutical product were estimated. Based on the TTC approach of Cramer class I substances, i.e. 1800 mg/（day？person）, the toxicity-qualified specification limits of acetol in topical excipients were calculated to be 90 mg/mL and 180 mg/mL for propylene glycol and glycerol, respectively.

关键词： Acetol Impurity Excipients Transdermal penetration Specification limits

A critical quality parameter in quantitative fused-core chromatography: The injection volume

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Journal of Pharmaceutical Analysis 2013年第5期3卷 330-334页

作者： Jente boonen Matthias D’hondt Lieselotte Veryser Kathelijne Peremans Christian Burvenich Bart De Spiegeleer Drug Quality and Registration (DruQuaR) Group Faculty of Pharmaceutical Sciences Ghent University Department of Veterinary Medical Imaging and Small Animal Orthopaedics Faculty of Veterinary Medicine Ghent University Department of Comparative Physiology and Biometrics Faculty of Veterinary Medicine Ghent University

As part of the method development, the injection volume as a critical quality attribute in fast fused-core chromatography was evaluated. Spilanthol, a pharmaceutically interesting N- alkylamide currently under investigation in our laboratory, was chosen as the model compound. Spilanthol was dissolved in both PBS and MeOH/H20 （70/30, v/v） and subsequently analyzed using a fused-core system hereby selecting five chromatographic characteristics （retention time, area, height, theoretical plates and symmetry factor） as responses. We demonstrated that the injection volume significantly influenced both the qualitative and quantitative performance of fused-core chromatography, a phenomenon which is confounded with the nature of the used sample solvent. From 2 ~tL up to 100 laL injection volume with PBS as solvent, the symmetry factor decreased favorably by 20%. Moreover, the theoretical plates and the quantitative parameters （area and height） increased up to 30%. On the contrary, in this injection volume range, the theoretical plates for the methanol-based samples decreased by more than 60%, while the symmetry factor increased and the height decreased, both by 30%. The injection volume is thus a critical and often overlooked parameter in fused-core method description and validation.

关键词： Spilanthol Fused-core (pore-shell,Halo) HPLC Superficially porousparticles (SPP) Injection volume ToPical patch Critical quality method-attribute (CQA)

Cost-effectiveness of patient specific vs conventional instrumentation for total knee arthroplasty:A systematic review and meta-analysis

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World Journal of Orthopedics 2023年第6期14卷 458-470页

作者： Isobel M Dorling Lars Geenen Marion J L F Heymans Jasper Most Bert boonen Martijn G M Schotanus Department of Orthopaedic Surgery and Traumatology Zuyderland Medical CenterSittard-Geleen 6162 BGLimburgNetherlands Zuyderland Academy Zuyderland Medical CenterSittard-Geleen 6155 NHLimburgNetherlands School of Care and Public Health Research Institute(CAPHRI) Faculty of HealthMedicine and Life SciencesMaastricht 6229 ERLimburgNetherlands Department of Orthopaedic Surgery and Traumatology Maastricht University Medical CenterMaastricht 6229 HXLimburgNetherlands

BACKGROUND Over the past years,patient specific instrumentation(PSI)for total knee arthroplasty(TKA)has been implemented and routinely *** clear answer has been given on its associated cost and cost-effectiveness when compared to conventional instrumentation(CI)for *** To compare the cost and cost-effectiveness of PSI TKA compared to CI *** A literature search was performed in healthcare,economical healthcare,and medical databases(MEDLINE,EMBASE,CINAHL,Web of Science,Cochrane Library,EconLit).It was conducted in April 2021 and again in January *** literature included randomised controlled trials,retrospective studies,prospective studies,observational studies,and case control *** studies were assessed on methodological *** outcomes included incremental cost-effectiveness ratio,quality-adjusted life years,total costs,imaging costs,production costs,sterilization associated costs,surgery duration costs and readmission rate *** eligible studies were assessed for risk of ***-analysis was performed for outcomes with sufficient *** Thirty-two studies were included into the systematic *** were included in the metaanalysis.3994 PSI TKAs and 13267 CI TKAs were included in the sample *** methodological quality of the included studies,based on Consensus on Health Economic Criteria-scores and risk of bias,ranged from average to *** TKA costs less than CI TKA when considering mean operating room time and its associated costs and tray sterilization per patient *** TKA costs more compared to CI TKA when considering imaging and production *** total costs per patient case,PSI TKA is more expensive in comparison to CI ***-analysis comparing total costs for PSI TKA,and CI TKA showed a significant higher cost for PSI *** Cost for PSI and CI TKA can differ when considering distinct aspects of their *** costs per patient case are increased for PSI TKA whe

关键词： Total knee arthroplasty Patient specific instrumentation Instrumentation for total knee arthroplasty Cost-effectiveness Systematic review

Patient specific guides for total knee arthroplasty are ready for primetime

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World Journal of Orthopedics 2016年第1期7卷 61-68页

作者： Martijn GM Schotanus Bert boonen Nanne P Kort Depart-ment of Orthopaedic Surgery Zuyderland Medical Centre

AIM: To present the radiological results of total knee arthroplasty(TKA) with use of patient specific matched guides(PSG) from different manufacturer in patients suffering from severe osteoarthritis of the knee ***: This study describes the results of 57 knees operated with 4 different PSG systems and a group operated with conventional instrumentation(n = 60) by a single surgeon. The PSG systems were compared with each other and subdivided into cut- and pin PSG. The biomechanical axis [hip-knee-ankle angle(HKA)], varus/valgus of the femur [frontal femoral component(FFC)] and tibia(frontal tibial component) component, flexion/extension of the femur [flexion/extension of the femur component(LFC)] and posterior slope of the tibia [lateral tibial component(LTC)] component were evaluated on long-leg standing and lateral X-rays. A percentage of > 3° deviation was seen as an outlier. RESULTS: The inter class correlation coefficient(ICC) revealed that radiographic measurements between both assessors were reliable(ICC > 0.8). Fisher exact test was used to test differences of proportions. The percentage of outliers of the HKA-axis was comparable between both the PSG and conventional groups(12.28% vs 18.33%, P < 0.424) and the cut- and pin PSG groups(14.3% vs 10.3%, P < 1.00). The percentage of outliers of the FFC(0% vs 18.33%, P < 0.000), LFC(15.78% vs 58.33%, P < 0.000) and LTC(15.78% vs 41.67%, P < 0.033) were significant different in favour of the PSGgroup. There were no significant differences regarding the outliers between the individual PSG systems and the PSG group subdivided into cut- and pin ***: PSG for TKA show significant less outliers compared to the conventional technique. These single surgeon results suggest that PSG are ready for primetime.

关键词： Total knee arthroplasty Patient specific matched guides Patient matched instruments Single surgeon Alignment Conventional instruments Cutting guides Pin guides

整合患者导向的测量工具项目编制等距量表实现ICF类目用于评定的可操作化

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中国康复理论与实践 2011年第2期17卷 129-136页

作者： Cieza A Hilfiker R boonen a Chatterji N Kostanjsek N stün BT Stucki G 叶祥明朱根应田亮邱卓英浙江省人民医院浙江杭州市310014 中国康复研究中心北京市100068

目的通过整合不同的患者导向的测量工具的项目来编制ICF特定类目的等距量表结构。方法使用有效的122例类风湿关节炎患者的样本资料进行心理测量研究。患者完成6个不同的以患者导向的测量工具。将这些测量工具项目的内容与ICF类目进行匹... 详细信息

目的通过整合不同的患者导向的测量工具的项目来编制ICF特定类目的等距量表结构。方法使用有效的122例类风湿关节炎患者的样本资料进行心理测量研究。患者完成6个不同的以患者导向的测量工具。将这些测量工具项目的内容与ICF类目进行匹配。对项目反应等级进行Rasch分析用于检查这些测量工具项目是否说明了ICF类目b130:能量和驱力功能,从而构成一个心理测量可靠的等距量表。结果 19个项目与b130能量和驱力功能有关。根据2χ检验和Z值统计,19个项目中的16个项目拟合Rasch模型(项目和个人的ZMean=0.451,ZSD=1.085和ZMean=-0.223,ZSD=1.132)。Person分离指数rβ是0.93。结论可以构建ICF类目等距量表使得单个ICF类目可操作化。每个项目的原始格式在等距量表中保持不变。本研究在ICF的操作和将来的实施方面迈出了重要的一步。

关键词：结局评定健康心理测量分类问卷

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运用ICF评定肌肉骨骼系统健康状况的影响

中国康复理论与实践 2011年第2期17卷 115-128页

作者： Nenad Kostanjsek Reuben Escorpizo Annelies boonen Nicolas E.Walsh Tefvik Bedirhan stün Gerold Stucki 李晶晶祝捷邹智荀芳邱卓英武汉大学中南医院康复医学科湖北武汉市430071 中国康复研究中心北京市100068

目的建议联合使用国际疾病分类(ICD)及国际功能、残疾和健康分类(ICF),并应用肌肉骨骼系统(MSK)状况的例子来说明运用方法。方法根据在ICD中MSK状况的分类和现有的ICF核心分类集(ICF Core Sets)MSK状况的类目作为备选类目来专门说明专... 详细信息

目的建议联合使用国际疾病分类(ICD)及国际功能、残疾和健康分类(ICF),并应用肌肉骨骼系统(MSK)状况的例子来说明运用方法。方法根据在ICD中MSK状况的分类和现有的ICF核心分类集(ICF Core Sets)MSK状况的类目作为备选类目来专门说明专项功能。另一方法是考虑来自在文献中出现的已经应用的测量方法或工具的类目。结果从6个MSK状况的核心分类集、两种特定的保健治疗环境、一种MSK临床研究环境和8篇工具相关的文献中抽取相关的ICF类目。结论 ICD-ICF联合使用通过考虑疾病和功能状况来强调健康状况的影响,从而促进临床保健治疗。因此,有证据显示,在ICD修订版背景下ICD和ICF之间有可操作性的联系和互补作用。

关键词：国际疾病分类诊断 ICF 分类结局测量公共卫生