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Yosuke Harada,1 Tomoyuki Akita,2 Joji Takenaka,1 Yuko Nakamura-Kadohiro,1 Junko Tanaka,2 Yoshiaki Kiuchi1 1Department of Ophthalmology and Visual Science, Graduate School of Biomedical Sciences, 2Department of Epidemiology, Infectious Disease Control and Prevention, Institute of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan Aim: The aim of this study was to determine the reproducibility and reliability of optic disk evaluation in supine subjects with a Heidelberg Retina Tomograph II (HRT II).Methods: One eye was randomly selected for evaluation by HRT II in each of eleven healthy subjects. Five images were obtained by each of two experienced operators at two separate visits with the subjects in both sitting and supine positions. A stand was constructed to allow stable, handheld operation of the HRT II head for imaging of the supine subjects. Measurements of optic disk parameters obtained in the supine position were compared with those obtained in the sitting position. The reliability of measurements in the supine position was evaluated by calculating both the coefficients of variation for measurements made by one observer on the first visit and the interobserver and intervisit intraclass correlation coefficients (ICCs); the values obtained were compared with those obtained for the sitting position. Results: Measurements of all parameters made in the supine position were highly similar to those made in the sitting position. The coefficients of variation obtained for each parameter in the sitting and supine positions ranged from 5.67% to 14.16% and from 2.18% to 16.08%, respectively. The interobserver ICC values in the sitting and supine positions were ≥0.978 and ≥0.989, respectively. The intervisit ICC values in the sitting and supine positions were ≥0.958 and ≥0.983, respectively.Conclusion: Handheld operation of the HRT II in a custom-designed stand is feasible for optic disk evaluation in the supine subjects who were not able to maintain the sitting position. Keywords: glaucoma, optic disk evaluation, supine position, Heidelberg retina tomograph

The global market for biopharmaceuticals is currently growing, and lyophilization is becoming increasingly important. Lyophilization is a time- and cost-consuming process for which the programs and recipes must be optimized to ensure product quality with minimum process time. However, a sufficient number of experiments for optimization of production-scale lyophilizers have not been performed due to limitations in actual pharmaceutical development, and a breakthrough approach is required to establish optimal lyophilization conditions with the limited experimental data available. Although there are a great number of published works associated with lyophilization of pharmaceutical products, the scale-up/tech transfer of the lyophilization process for biopharmaceuticals is still difficult. This review aims to discuss the difficulty of process development of lyophilization from an industry perspective and to introduce promising novel technologies and approaches and new findings related to successful lyophilization of biopharmaceuticals. [ABSTRACT FROM AUTHOR]

The objective of this study was to investigate the presence of tumor necrosis factor-[alpha] (TNF-[alpha]) in the central nervous system and the effects of lipopolysaccharide on central and peripheral concentrations of TNF-[alpha], behavioral conditions (standing or lying), elimination scores (defecation or urination), rectal temperature, and food intake (as-fed basis) in Chinese Meishan pigs. Intravenous injections of lipopolysaccharide resulted in increased (P < 0.05) plasma concentrations of TNF-[alpha] and cortisol. Although urination was not alfected by the administration of lipopolysaccharide, defecation was stimulated (P < 0.05). Lipopolysaccharide increased (P < 0.05) rectal temperature and standing rate, and inhibited (P < 0.05) food intake in pigs. To determine whether TNF-[alpha] is present in the porcine central nervous system as well as in peripheral blood, TNF-[alpha] and its specific transcripts in brain tissues (hypothalamus, amygdala, or hippocampus) and the pituitary were determined. The abundance of TNF-[alpha] messenger RNA and immunoreactive TNF-[alpha] were observed in all tissues, and the concentrations of TNF-[alpha] were increased (P < 0.05) by the intramuscular injection of lipopolysaccharide. These results suggest that TNF-[alpha] is present in the central nervous system, and plays some roles in its biological regulation in Chinese Meishan pigs. Key Words: Brain, Lipopolysaccharides, Meishan, Pigs, Pituitary, Tumor Necrosis Factor