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.
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.

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/H2O (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 mL up to 100 mL 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.

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。

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χ2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。