Inter- and intralaboratory variation of in vitro diffusion cell measurements: An international multicenter study using quasi-standardized methods and materials

In vitro measurements of skin absorption are an increasingly important aspect of regulatory studies, product support claims, and formulation screening. However, such measurements are significantly affected by skin variability. The purpose of this study was to determine inter- and intralaboratory variation in diffusion cell measurements caused by factors other than skin. This was attained through the use of an artificial (silicone rubber) rate-limiting membrane and the provision of materials including a standard penetrant, methyl paraben (MP), and a minimally prescriptive protocol to each of the 18 participating laboratories. Standardized calculations of MP flux were determined from the data submitted by each laboratory by applying a predefined mathematical model. This was deemed necessary to eliminate any interlaboratory variation caused by different methods of flux calculations. Average fluxes of MP calculated and reported by each laboratory (60 +/- 27 mug cm(-2) h(-1), n = 25, range 27-101) were in agreement with the standardized calculations of MP flux (60 +/- 21 mug cm(-2) h(-1), range 19-120). The coefficient of variation between laboratories was approximately 35% and was manifest as a fourfold difference between the lowest and highest average flux values and a sixfold difference between the lowest and highest individual flux values. Intra-laboratory variation was lower, averaging 10% for five individuals using the same equipment within a single laboratory. Further studies should be performed to clarify the exact components responsible for nonskin-related variability in diffusion cell measurements. It is clear that further developments of in vitro methodologies for measuring skin absorption are required. (C) 2005 Wiley-Liss, Inc.

Low back pain patients demonstrate increased hip extensor muscle activity during standardized submaximal rotation efforts

Study Design. A comparative study of trunk and hip extensor muscle recruitment patterns in 2 subject groups. Objective. To examine for changes in recruitment of the hip and back extensor muscles during low level isometric trunk rotation efforts in chronic low back pain (CLBP) subjects by comparison with matched asymptomatic control subjects. Summary of Background Data. Anatomic and biomechanical models have provided evidence that muscles attaching to the thoracolumbar fascia (TLF) are important for providing stabilization to the lumbopelvic region during trunk rotation. This has guided rehabilitation programs. The muscles that link diagonally to the posterior layer of the TLF have not previously been examined individually and compared during low-level trunk rotation efforts in CLBP patients and matched controls. Methods. Thirty CLBP patients and 30 matched controls were assessed using surface electromyography (EMG) as they performed low-level isometric rotation efforts while standing upright. Muscles studied included latissimus dorsi, erector spinae, upper and lower gluteus maximus, and biceps femoris. Subjects performed the rotation exertion with various levels of external trunk support, related to different functional tasks. Results. EMG results demonstrated that subjects with CLBP had significantly higher levels of recruitment for the lower and upper gluteus maximus (P < 0.05), hamstrings (P < 0.05), and erector spinae muscles (P < 0.05) during rotation to the left compared with the control subjects. Conclusion. This study provided evidence of increased muscle recruitment in CLBP patients when performing a standardized trunk rotation task. These results may have implications for the design of therapeutic exercise programs for CLBP patients.