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关键词： 口服固体制剂   生物等效性   注册申请   仿制药   样品   分类   化学   国务院办公厅  

摘要： 为贯彻中共中央办公厅、国务院办公厅《关于深化审评审批制度改革鼓励药品医疗器械创新的意见》（厅字[2017]42号）、国务院办公厅《关于改革完善仿制药供应保障及使用政策的意见》（国办发[2018]20号）精神，促进仿制药研发，完善仿制药注册申请的技术标准，保证商业化生产批次样品与生物等效性研究批次样品质量与疗效的一致性，国家药审中心起草制定了《注册分类4、5．2类化学仿制药（口服固体制剂）生物等效性研究批次样品批量的一般要求（试行）》，予以发布。

关键词： 暴雨   急流   超低空急流脉动   模式预报检验  

摘要： 利用NCEP fnl 1°×1°全球资料、常规气象观测资料和风廓线雷达资料,从急流角度入手对2014年5月16-18日江西中北部地区的暴雨过程进行诊断分析。结果表明,超低空、低空急流的加强为暴雨区持续提供能量以及水汽,且急流前端辐合抬升加强了上升运动;高空200 h Pa我国东北地区低涡和南亚高压配合形成的分流区产生的辐散作用对降水存在促进作用;超低空急流脉动有利于强降水的产生;高、低空急流的适宜配置产生的动力场耦合作用,为大暴雨的发生、发展提供非常有利的动力条件。对模式风场预报检验发现,模式预报稳定性较好,但是模式预报在急流核强度上与实况存在一些差别。

关键词： circulating tumor cells   CellSearch (R)   EpCAM   leukocytes   ACCEPT   deep Learning   classification   image analysis   non-small cell lung cancer   CIRCULATING TUMOR-CELLS   WHEAT-GERM-AGGLUTININ   LUNG-CANCER   SURVIVAL   PROGRESSION   PROSTATE   BLOOD  

摘要： In the CellSearch (R) system, blood is immunomagnetically enriched for epithelial cell adhesion molecule (EpCAM) expression and cells are stained with the nucleic acid dye 4'6-diamidino-2-phenylindole (DAPI), Cytokeratin-PE (CK), and CD45-APC. Only DAPI+/CK+ objects are presented to the operator to identify circulating tumor cells (CTC) and the identity of all other cells and potential undetected CTC remains unrevealed. Here, we used the open source imaging program Automatic CTC Classification, Enumeration and PhenoTyping (ACCEPT) to analyze all DAPI+ nuclei in EpCAM-enriched blood samples obtained from 192 metastatic non-small cell lung cancer (NSCLC) patients and 162 controls. Significantly larger numbers of nuclei were detected in 300 patient samples with an average and standard deviation of 73,570 +/- 74,948, as compared to 359 control samples with an average and standard deviation of 4191 +/- 4463 (p < 0.001). In patients, only 18% +/- 21% and in controls 23% 15% of the nuclei were identified as leukocytes or CTC. Adding CD16-PerCP for granulocyte staining, the use of an LED as the light source for CD45-APC excitation and plasma membrane staining obtained with wheat germ agglutinin significantly improved the classification of EpCAM-enriched cells, resulting in the identification of 94% +/- 5% of the cells. However, especially in patients, the origin of the unidentified cells remains unknown. Further studies are needed to determine if undetected EpCAM+/DAPI+/CK-/CD45-CTC is present among these cells.

关键词： cancer patient   Cancer   Teams  

关键词： Text classification   Semi-supervised learning   Sample extension   Wikipedia  

摘要： Text classification is a topic in natural language processing that is particularly useful for Internet information processing. Methods based on supervised learning require a large amount of manually annotated training samples. The annotation of training samples is time consuming, and performance relies heavily on the quality of the training samples. This paper presents a text classification method based on sample extension. The extension is based on the correlation of the labeled sample data and the concepts in Wikipedia. Combined with the rich link relationships between concepts, we selected appropriate articles from Wikipedia to expand the training sample set. By introducing the large amount of rich semantic concept pages that are contained in Wikipedia along with links that are related to different pages, our approach enhances the performance and generalization of the classifier. Experiments demonstrate that the performance of the method proposed in this paper is better than that of both supervised and semi-supervised methods.

关键词： Medical   Problem solving  

关键词： Pharmaceutical advertising   pharmaceutical products   drugs for anxiety   drugs for psychosis   drugs for anxiety   drugs for insomnia   sedatives   BENZEDRINE SULFATE   AMPHETAMINE   BARBITURATE   DISORDERS  

摘要： Background: Many modern pharmaceutical products were launched during 1950-1980, as reflected in advertisements in the British Medical Journal (BMJ). One of the first therapeutic areas to benefit from novel effective medications was psychiatry. Methods: We examined BMJ advertising material between 1950 and 1980, including every other issue over six-month periods (October-March) in 1950/1951, 1955/1956, 1957/1958, 1960/1961, 1962/1963, 1965/1966, 1967/1968, 1970/1971, 1972/1973, 1975/1976, 1980/1981. We recorded numbers of adverts for all pharmaceutical products and for psychiatric drugs; we also recorded trade names, generic names and marketing company. Results: Advertising in BMJ peaked in the 1960s and declined markedly in the 1970s. Adverts for psychiatric drugs as a percentage of total pharmaceutical product advertising was broadly similar during 1955-1980, but with peaks in 1960/1961, 1970/1971 and 1975/1976, reflecting the entry of several novel compounds into the market. The peak marketing of antipsychotic drugs, sedatives and anxiolytic drugs was in 1960 and of antidepressants 1970. The time course of the rise of tricyclics and the switch from barbiturates to benzodiazepines can be seen. Drugs for psychiatry rose from ninth (1955/1956) to fourth (1975/1976) in terms of the number of products in the top 10 therapeutic areas. There is no evidence that they were advertised more aggressively (number of adverts/number of products). Conclusions: The birth of modern psychopharmacology is reflected in the advertising of psychiatric drugs in BMJ. Many drugs currently used, or their closely related successors, were launched in the early to mid-1960s. This rise in modern pharmaceuticals preceded several other major therapeutic areas.

关键词： Green coffee   Caffeine   Chlorogenic acid (5-caffeoylquinic acid)   HPLC-DAD   Multivariate curve resolution (MCR)   Classification   Partial least squares discriminant analysis (PLS-DA)   Soft independent modeling of class analogies (SIMCA)   MULTIVARIATE CURVE RESOLUTION   OVERLAPPING CHROMATOGRAPHIC PEAKS   EVOLVING FACTOR-ANALYSIS   PARTIAL LEAST-SQUARES   CARDIOVASCULAR-DISEASE   NICOTINIC-ACID   EXTRACTION   HEALTH   RISK   TRIGONELLINE  

摘要： A chromatographic procedure (HPLC-DAD) using a relatively rapid gradient has been combined with a chemometric curve deconvolution method, multivariate curve resolution-alternating least squares (MCR-ALS), in order to quantify caffeine and chlorogenic acid in green coffee beans. Despite that the HPLC analysis (at these specific operating conditions) presents some coeluting peaks, MCR-ALS allowed their resolution and, consequently, the creation of a calibration curve to be used for the quantification of the analytes of interest; this procedure led to a high accuracy in the quantification of caffeine and chlorogenic acid present in the samples. In a second part of this study, the possibility of classifying the green coffee beans on the basis of their cultivar (Arabica or Robusta), by partial least squares discriminant analysis (PLS-DA) and soft independent modeling of class analogies (SIMCA), has been explored. SIMCA resulted in 100% of sensitivity and specificity for the Arabica class, while for the Robusta, it reached 66.7% of sensitivity and 100% of specificity, or 100% of sensitivity and 100% of specificity, depending on the extraction procedure followed prior to the chromatographic analysis; PLS-DA achieved 100% of correct classification independently of the procedure used for the extraction.