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191.
192.
Takayuki Anzai Masamichi Kaminishi Keizo Sato Laura Kaufman Hijiri Iwata Dai Nakae 《Journal of toxicologic pathology》2015,28(2):57-64
The Standard for the Exchange of Nonclinical Data (SEND), adopted by the US FDA, is part of a set of regulations and guidances requiring the submission of standardized electronic study data for nonclinical and clinical data submissions. SEND is the nonclinical implementation of SDTM (Study Data Tabulation Model), the standard electronic format for clinical regulatory submissions to FDA. SEND, SDTM, and the associated Controlled Terminology have been developed by CDISC (Clinical Data Interchange Standards Consortium). In order to successfully implement SEND, interdisciplinary contributions between sponsors and CROs, need a model for task allocation. This is being undertaken by the Pharmaceutical Users Software Exchange (PhUSE). Because SEND is currently the preferred submission format of the US FDA only and will become required by it starting in December 2016, only American academic societies and companies are actively involved. An exception to this is the INHAND initiative, which leads the way in standardizing terminology for toxicological pathology. On the other hand, international globalization of other clinical and nonclinical practices is not feasible because there are substantial differences between the US and non-US countries in CRO involvement in drug development. Thus, non-US countries must consider and develop approaches to SEND that meet their needs. This paper summarizes the activities of the major organizations involved in SEND development and implementation, discusses the effective use of SEND, and details a compliance scheme (research material of the Showa University School of Medicine) illustrating how pharmaceutical companies can complete a large amount of work up to an FDA application with the effective utilization of CROs and solution providers. 相似文献
193.
Serge MORAND Frédéric BORDES Hsuan‐Wien CHEN Julien CLAUDE Jean‐François COSSON Maxime GALAN Gábor Á CZIRJÁK Alex D GREENWOOD Alice LATINNE Johan MICHAUX Alexis RIBAS 《Integrative zoology》2015,10(5):409-423
We summarize the current knowledge on parasitism‐related invasion processes of the globally invasive Rattus lineages, originating from Asia, and how these invasions have impacted the local epidemiology of rodent‐borne diseases. Parasites play an important role in the invasion processes and successes of their hosts through multiple biological mechanisms such as “parasite release,” “immunocompetence advantage,” “biotic resistance” and “novel weapon.” Parasites may also greatly increase the impact of invasions by spillover of parasites and other pathogens, introduced with invasive hosts, into new hosts, potentially leading to novel emerging diseases. Another potential impact is the ability of the invader to amplify local parasites by spillback. In both cases, local fauna and humans may be exposed to new health risks, which may decrease biodiversity and potentially cause increases in human morbidity and mortality. Here we review the current knowledge on these processes and propose some research priorities. 相似文献
194.
为探讨水稻土胶体与类金属砷(As)的生物地球环境行为,本研究对比分析了微生物在初始pH=3和初始pH=7的不同酸碱条件下对土壤胶体负载As释放的作用差异,并揭示其内在机制。结果表明:在pH=3条件下微生物作用相对较弱,对胶体悬液pH与Eh影响较小,与无菌对照组相比,溶液中Fe2+与As含量均有所提高,且释放的As主要为氧化态As(Ⅴ);在pH=7条件下微生物活性较强,至28 d时可使胶体悬液pH升至8.12,Eh降至-55 mV,形成强还原环境,铁还原溶解量明显增多,Fe2+含量是无菌对照组的2.79倍,并且胶体中吸附态As随着Fe的还原溶解而释放,主要为还原态As(Ⅲ)。相关性分析表明,土壤胶体中As的释放与铁氧化物的还原转化有关,溶液中As释放量与Fe2+含量呈显著正相关关系,尤其在中性条件下As(Ⅲ)含量与Fe2+极显著正相关(r=0.798**,P<0.01)。研究表明,在中性环境条件下较强的微生物活性可提高土壤胶体中铁氧化物的异化还原,同时增强As的释放与转化。 相似文献
195.
灵山岛浅海岩礁区刺参增殖放流研究 总被引:1,自引:0,他引:1
1991-1992年在灵山岛西侧海区进行了刺参增殖放流试验。结果表明,笼播参苗在自然海区比较安全,参苗存活率为10%左右。撒播参苗因短期内较骓适应自然海况,易被海流带走等多种因素,参苗存活率甚低。 相似文献
196.
绥芬河滩头雅罗鱼孵化放流的初步试验 总被引:1,自引:0,他引:1
本文首次报道绥芬河滩头雅罗鱼大批量人工孵化放流。1989年5~6月,在绥芬河东宁河段采捕、利用(?)河亲鱼3037尾,采卵1867万粒,利用自然产卵场生态条件孵化放流的雅鱼1323万尾(全长6.5mm)。 相似文献
197.
A standing surgical technique for splitting the medial patellar ligament is described, and the long-term (average 4.5-years) efficacy of the procedure in horses exhibiting delayed patellar release is reported. Medical records of 64 horses that underwent a standing medial patellar ligament splitting surgery performed to treat delayed patellar release were analyzed retrospectively. Horses were sedated in standing stocks. A number 15 scalpel blade was used to percutaneously split the medial patellar ligament from just proximal to its insertion on the tibial tuberosity to its attachment on the parapatellar fibrocartilage, with the goal of inducing a localized desmitis and subsequent thickening of the ligament. Aftercare consisted of oral antibiotics, 14 days stall rest with hand walking, light exercise for 14 days, and full work at 4 weeks. Follow-up information was obtained through telephone calls to owners and/or clinical evaluation by a veterinarian. Results showed that 89% of horses benefitted from the procedure, with complete resolution in 58% of horses and improvement in 31% of horses. A total of 73% of horses were able to perform at the desired level following the procedure; 63% of horses showed signs of improvement or resolution within 30 to 60 days. Two horses had complications following the procedure: 1 horse had an incisional infection, and 1 had a medial patellar ligament rupture. This study shows that standing medial patellar ligament splitting is a successful, long-term surgical option for treatment of delayed patellar release. The procedure has few complications and allows rapid return to desired performance. 相似文献
198.
浙北沿岸大黄鱼放流增殖的初步研究 总被引:9,自引:2,他引:9
为了恢复浙江渔场大黄鱼资源,1998—2002年,浙江省在浙江北部沿岸海域进行了大黄鱼增殖放流可行性研究。通过5年来的放流试验表明,在浙北沿岸进行大黄鱼放流是完全可行的,放流鱼能够在放流区域附近海域存活、生长,并进行索饵、产卵洄游,同时形成了一定数量的捕捞群体,放流鱼回捕率较高,放流效果较好。文章对试验放流过程中出现的问题进行了探讨和分析,为今后进一步大规模放流提出了建议。 相似文献
199.
200.
Yoshimasa Sugiura Yoshirou Takeuchi Makoto Kakinuma Hideomi Amano 《Fisheries Science》2006,72(6):1286-1291
ABSTRACT: The effects of 80% methanol extracts from frozen samples of 41 macroalgae and one sea grass collected in the Ise-Shima region of Japan were investigated on histamine release from rat basophile leukemia cells (RBL-2H3) sensitized with antidinitrophenyl (DNP) IgE and stimulated with DNP-BSA. Of the 21 brown algae, five green and 15 red algae, and one sea grass tested, only extracts from seven brown algae suppressed histamine release from RBL cells, as determined by high-performance liquid chromatography (HPLC) analysis. When the cytotoxic effects of the seven brown algal extracts were investigated by Trypan blue staining, only Eisenia arborea and Sargassum thunbergii did not show cytotoxic effects. Therefore, we conclude that E. arborea and S. thunbergii may contain compounds that have antiallergic effects without inducing cell death. 相似文献