Innovation in Chemistry,Manufacturing, and Controls—A Regulatory Perspective From Industry

This review describes the landscape of novel modalities such as cell and gene therapies, viruses, other novel biologics, oligomers, and emerging technologies, including modern analytics. We summarize the regulatory history and recent landmark developments in some major markets and examine specific chemistry, manufacturing, and controls (CMC) challenges, including suggestions for exploration of potential science-based approaches in support of regulatory strategy development from an industry perspective. In addition, we evaluate the economic factors contributing to patient access to innovation and discuss the impact of regulation. There is a desperate need for a consistent form of regulation where global approaches to regulatory strategies can be harmonized, and specific CMC challenges can be dealt with using the appropriate science and risk-based tools. Although these tools are well described in current guidance documents, the specifics of applicability to complex novel modalities can still result in differing regulatory advice and outcomes. The future goals for efficiently regulating innovative modalities and technologies could be aided by more regulatory harmonization, regulatory education, and industry cooperation through consortia, enabling industry to supply key information to regulators in a transparent yet well-defined manner, and utilizing mutually understood risk-benefit analyses to produce drugs with appropriate safety, efficacy, and quality characteristics.     

Transgender pediatric surgical patients—Important perioperative considerations

Transgender describes a variety of identities in which an individual's gender identity is different from expected based on the sex assigned at birth. In the United States, it is estimated that over 1 million adults and 150 000 youth identify as transgender, with increasing numbers being seen in healthcare and surgical settings. These numbers will continue to rise as visibility and acceptance grow. Current guidelines recommend transition‐related surgeries be reserved for older adolescents and adults. However, this is not the only circumstance in which the pediatric anesthesiologist may find themselves caring for a transgender patient. In order to provide the safest and most affirming care, it is crucial that the pediatric anesthesiologist develop a working knowledge of this unique and vulnerable population, including the potential impacts of gender‐affirming treatment on their perioperative care.     

一种高效、快速的大肠杆菌感受态细胞制备及质粒转化方法

目的：建立一种高效、快速的大肠杆菌感受态细胞制备及质粒转化的方法。方法：质粒DNA加入感受态细胞，经短暂冰浴和热休克后，直接涂布预热至37℃的平板。以大肠杆菌DH5α为受体菌，研究CaCl2溶液浓度、感受态细胞的存放时间、转化时间及转化后的培养时间等对质粒转化效率的影响。结果：以100mmol／L CaCl2溶液制备感受态细胞，冰浴转化5min，经42℃热休克作用908后直接涂平板筛选转化子，获得与常规转化方法相当的转化效率。CaCl2溶液浓度和感受态细胞的存放时间对转化效率有明显的影响，而转化时间和转化后的振荡培养时间对转化效率的影响不明显。结论：成功地建立了一种高效、快速的感受态细胞制备及质粒转化的方法。     

Establishment of Germ-line Competent C57BL/6J Embryonic Stem Cell Lines

Objective To establish C57BL/6J embryonic stem （ES） cell lines with potential germ- line contribution Methods ES cells were isolated from blastocyst inner cell mass of C5 7BL/6J mice, and cultured for 15 passages, and then injected into blastococels of ICR mice blastocysts to establish chimeric mice. Results Three ES cell lines （mC57ES1,mC57ES3, mC57ES7） derived from the inner cell mass of C57BL/6J mice blastocysts were established. They were characteristic of undifferentiated state, including normal XY karyotype, expression of a specific cell surface marker “stage-specific embryonic antigen-I” and alkaline phosphatase in continuous passage. When injected into immunodeficient mice, mC57ES1 cells consistently differentiated into derivatives of all three embryonic germ layers. When mC57ES1 cells were transferred into ICR mice blastocysts, 4 chimeric mice have been obtained. One male of them revealed successful germ-line transmission. Conclussion We have obtained C57BL/6J ES cell lines with a potential germ-line contribution, which can be used to generate transgenic and gene knock-out mice.     

Hearing the voices of children with chronic illness

This qualitative study has aimed to explore children's, parents' and health professionals' experience of childhood chronic illness. Seven families and their professional carers participated in semistrucured interviews. The children's interviews were augmented with a 'drawing' technique. A grounded theory approach facilitated data collection and analysis. This paper debates the perceived passivity of the voice of children in health care and research and illustrates data collection methods that seek to give children and other disadvantaged groups a voice. The children who participated in this study are described as competent interpreters of their world.     

Expected contribution to serum oestradiol from individual ovarian follicles in unstimulated cycles

Data relating serum oestradiol concentration to follicle size in unstimulated cycles are lacking. We provide precise data on serum concentrations expected for any follicle diameter (FD) in the mid- to late follicular phase. Infertile women (n = 35) with apparently normal ovulatory cycles were studied in detail in 128 unstimulated monofollicular cycles leading to IVF. Using mathematical modelling to account for repeated cycles in the same woman, the relationship between serum oestradiol and FD was explored and reference ranges for serum oestradiol at individual FD were calculated. Serum oestradiol concentrations [number of patients, geometric mean, 95% confidence interval (CI)] at the onset of the LH surge were higher in 'fertilized' cycles (73, 1279, 1180-1378 pmol/l) compared with 'unfertilized' cycles (31, 1055, 929-1197 pmol/l, P: = 0.008) and 'no oocyte' cycles (24, 1064, 922-1227 pmol/l, P: = 0.03) respectively. In 'fertilized' cycles, oestradiol concentrations rose exponentially with FD and for each size of follicle the oestradiol distribution was skewed. Functional oocyte competence varied in apparently normal ovulatory cycles and was correlated with pre-ovulatory serum oestradiol but not FD. Serum oestradiol varies within wide limits for maturing follicles of any given diameter prior to the onset of the LH surge.     

Health literacy as the missing link in the provision of immigrant health care: A qualitative study of Southeast Asian immigrant women in Taiwan

ObjectivesLanguage and communication barrier are main contributors to poor health outcomes and improper use of health care among immigrants. The purpose of this study was to explore and understand specific language and communication problems experiences by Southeast Asian immigrant women in Taiwan.DesignThis qualitative study used focus groups and in-depth interviews to uncover the experiences of immigrant women regarding their access to and utilization of health care in Taiwan.ParticipantsEight focus groups were conducted with 62 Southeast Asian immigrant women and 23 individual in-depth interviews with a wide range of stakeholders who had diverse background and intimate knowledge of immigrant-relating health care issues were performed.ResultsDirected content analysis was applied and identified four major themes concerning conditions that influenced immigrant women's use of health information and services: (1) gaining access to health information, (2) navigating in health care delivery system, (3) interactions during health care encounters, and (4) capability of using health information and services. Findings from this study suggest that, without basic language and literate skills, the majority of immigrant women had inadequate health literacy to manage health information and navigate the Taiwan health care system. Interpersonal communication gap between immigrant women and health care providers exists because of lack of health literacy in addition al language and cultural barriers.ConclusionWith limited language and health literacy skills, immigrant women face numerous challenges in navigating the health care system, interacting with health care providers, and gaining access to proper health care. Future efforts are necessary to enhance individual's health literacy and establish health literate environment.     

Narrative inquiry: Locating Aboriginal epistemology in a relational methodology

BACKGROUND: This methodology utilizes narrative analysis and the elicitation of life stories as understood through dimensions of interaction, continuity, and situation. It is congruent with Aboriginal epistemology formulated by oral narratives through representation, connection, storytelling and art. Needed for culturally competent scholarship is an experience of research whereby inquiry into epiphanies, ritual, routines, metaphors and everyday experience creates a process of reflexive thinking for multiple ways of knowing. Based on the sharing of perspectives, narrative inquiry allows for experimentation into creating new forms of knowledge by contextualizing diabetes from the experience of a researcher overlapped with experiences of participants--a reflective practice in itself. AIM: The aim of this paper is to present narrative inquiry as a relational methodology and to analyse critically its appropriateness as an innovative research approach for exploring Aboriginal people's experience living with diabetes. NURSING APPLICATION: Narrative inquiry represents an alternative culture of research for nursing science to generate understanding and explanation of Aboriginal people's 'diabetic self' stories, and to coax open a window for co-constructing a narrative about diabetes as a chronic illness. The ability to adapt a methodology for use in a cultural context, preserve the perspectives of Aboriginal peoples, maintain the holistic nature of social problems, and value co-participation in respectful ways are strengths of an inquiry partial to a responsive and embodied scholarship.