Progress,innovation and regulatory science in drug development: the politics of international standard-setting     

Abraham J  Reed T 《Social studies of science》2002,32(3):337-369

This paper examines international standard-setting in the toxicology of pharmaceuticals during the 1990s, which has involved both the pharmaceutical industry and regulatory agencies in an organization known as the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The analysis shows that the relationships between innovation, regulatory science and 'progress' may be more complex and controversial than is often assumed. An assessment of the ICH's claims about the implications of 'technical' harmonization of drug-testing standards for the maintenance of drug safety, via toxicological testing, and the delivery of therapeutic progress, via innovation, is presented. By demonstrating that there is not a technoscientific validity for these claims, it is argued that, within the ICH, a discourse of technological innovation and scientific progress has been used by regulatory agencies and prominent parts of the transnational pharmaceutical industry to legitimize the lowering and loosening of toxicological standards for drug testing. The mobilization and acceptance of this discourse are shown to be pivotal to the ICH's transformation of reductions in safety standards, which are apparently against the interests of patients and public health, into supposed therapeutic benefits derived from promises of greater access to more innovative drug products. The evidence suggests that it is highly implausible that these reductions in the standards of regulatory toxicology are consistent with therapeutic progress for patients, and highlights a worrying aspect embedded in the 'technical trajectories' of regulatory science.  相似文献   

Translation, difference and ontological fluidity: cerebral angiography and neurosurgical practice (1926-45)     

Moreira T 《Social studies of science》2000,30(3):421-446

Cerebral angiography is nowadays a standard test in neurosurgical treatment. The coupling between such a diagnostic technique and neurosurgical practices is the outcome of a complex story. This paper explores that complexity. It does so by exploring the continuities and discontinuities between the multiple definitions and uses of angiography in the first 20 years of its history. It also investigates the relations between process and narrative in S&TS research, and suggests that it is possible to turn dis/continuity into an empirical question, viewing it as internal to the processes of socio-technical innovation as it becomes available in the practical engagements of the actors involved in those processes.  相似文献   

克服基因疗法的障碍   总被引：1，自引：0，他引：1  

Fried.  T 郑小石 《科学中国》1997,(11):46-51,57

提供必需的基因不治疗疾病的方法仍然是一个令人感兴趣的想法，然而在基因疗法成为现实之前，临床与基础研究人员仍有许多工作要做。  相似文献   

香港大学学术库——机构知识库的应用扩展     

Liu  Eliot Z H  Palmer  David T 《大学图书馆学报》2015,33(4):68-75

香港大学学术库是香港大学的机构知识库,是响应大学知识交流政策而建立的知识管理系统。凭借丰富的数据来源以及合理的设计机制,学术库已成为颇具影响力的香港大学人才和科研成果的展示平台,成为校内外学术交流的中心,为学术评估和声誉管理提供了基础。  相似文献   

Undergraduate research experiences in biology: alternatives to the apprenticeship model     

Wei CA  Woodin T 《CBE life sciences education》2011,10(2):123-131

  相似文献   

高职院校兼职教师政策演变与完善建议     

吴琼斯 《湖南大众传媒职业技术学院学报》2014,(5):113-116

国内高职院校兼职教师政策经过弥补期、确定期、规范期等演变过程,起到了明确兼职教师的概念内涵,界定兼职教师的功能定位,确定兼职教师的数量比例,解决兼职教师的经费来源等作用。结合国外发展经验,高职院校兼职教师政策可在提升企业积极性、完善教师资格、构建兼职教师转任专职等方面进行完善。  相似文献   

Revisiting the classics in childbirth education     

Shilling T  Bingham S 《The Journal of perinatal education》2010,19(3):73-78

In celebration of Lamaze International's 50th anniversary, reviewers share their thoughts on some classic Lamaze resource materials and how their content relates to today's viewpoints on birth and childbirth education. Although some of the material may be outdated, all of the resources offer timeless insights as well as a unique view on the history of childbirth education. The following topics are addressed: past cultural views of birth; advocacy for change in birth practices; Lamaze method; pioneers in childbirth; importance of childbirth education; and birth advocacy.  相似文献   

Mother and infant talk about mental states relates to desire language and emotion understanding   总被引：3，自引：0，他引：3  

Taumoepeau M  Ruffman T 《Child development》2006,77(2):465-481

This study assessed the relation between mother mental state language and child desire language and emotion understanding in 15-24-month-olds. At both time points, mothers described pictures to their infants and mother talk was coded for mental and nonmental state language. Children were administered 2 emotion understanding tasks and their mental and nonmental state vocabulary levels were obtained via parental report. The results demonstrated that mother use of desire language with 15-month-old children uniquely predicted a child's later mental state language and emotion task performance, even after accounting for potentially confounding variables. In addition, mothers' tendency to refer to the child's over others' desires was the more consistent correlate of mental state language and emotion understanding.  相似文献   

Reading fluency: The whole is more than the parts     

Katzir T  Kim Y  Wolf M  O'Brien B  Kennedy B  Lovett M  Morris R 《Annals of dyslexia》2006,56(1):51-82

This study examined the relative contributions of phonological awareness, orthographic pattern recognition, and rapid letter naming to fluent word and connected-text reading within a dyslexic sample of 123 children in second and third grades. Participants were assessed on a variety of fluency measures and reading subskills. Correlations and hierarchical multiple regression analyses were carried out to explore these relationships. The results demonstrate that phonological awareness, rapid letter naming, and orthographic pattern recognition contribute to word-reading skills. Furthermore, rapid naming, orthographic pattern recognition, and word reading fluency moderately predict different dimensions of connected-text reading (i.e., rate, accuracy, and comprehension) whereas phonological awareness contributes only to the comprehension dimension of connected-text reading. The findings support the multidimensional nature of fluency in which the whole is more than its parts.  相似文献   

Incidental word learning in a hearing child of deaf adults     

Brackenbury T  Ryan T  Messenheimer T 《Journal of deaf studies and deaf education》2006,11(1):76-93

It is unclear how children develop the ability to learn words incidentally (i.e., without direct instruction or numerous exposures). This investigation examined the early achievement of this skill by longitudinally tracking the expressive vocabulary and incidental word-learning capacities of a hearing child of Deaf adults who was natively learning American Sign Language (ASL) and spoken English. Despite receiving only 20% of language input in spoken English, the child's expressive vocabularies at 16 and 20 months of age, in each language, were similar to those of monolingual age-matched peers. At 16 months of age, the child showed signs of greater proficiency in the incidental learning of novel ASL signs than she did for spoken English words. At 20 months of age, the child was skilled at incidental word learning in both languages. These results support the methodology as it applies to examining theoretical models of incidental word learning. They also suggest that bilingual children can achieve typical vocabulary levels (even with minimal input in one of the languages) and that the development of incidental word learning follows a similar trajectory in ASL and spoken English.  相似文献