Publications by authors named "Yu-Mei Chiang"
Taiwan Food and Drug Administration (TFDA) was established in 2010 as the nation's principal consumer product protection agency of food, drugs, medical devices, and cosmetics. By integrating 4 agencies (the Bureau of Food Safety, Bureau of Pharmaceutical Affairs, Bureau of Food and Drug Analysis, and Bureau of Controlled Drugs), TFDA holds the mission of protecting and promoting the public health through regulation modernization to enhance the availability of safe medical products and foods. To address the unmet medical needs and public health, TFDA has utilized regulatory science to evaluate review principles and risk management to properly oversee the overall life cycle of medicinal products.
View Article and Find Full Text PDFOwing to the rapid and mature development of emerging biotechnology in the fields of cell culture, cell preservation, and recombinant DNA technology, more and more cell or gene medicinal therapy products have been approved for marketing, to treat serious diseases which have been challenging to treat with current medical practice or medicine. This chapter will briefly introduce the Taiwan Food and Drug Administration (TFDA) and elaborate regulation of cell and gene therapy medicinal products in Taiwan, including regulatory history evolution, current regulatory framework, application and review procedures, and relevant jurisdictional issues. Under the promise of quality, safety, and efficacy of medicinal products, it is expected the regulation and environment will be more flexible, streamlining the process of the marketing approval of new emerging cell or gene therapy medicinal products and providing diverse treatment options for physicians and patients.
View Article and Find Full Text PDFIdentification and quantification of Cu-chlorophyll adulteration of edible oils.
Food Addit Contam Part B Surveill
May 2016
Article Synopsis
- The study analyzed the presence of Cu-pyropheophytin a in edible oils using advanced mass spectrometry techniques, achieving low limits of detection and quantification of 0.02 μg/g and 0.05 μg/g, respectively.
- It investigated 29 commercial oils from a company involved in adulteration with Cu-chlorophyll, finding the pigment in all confiscated samples at levels ranging from 0.02 to 0.39 μg/g.
- A broader survey of 235 oil samples revealed significant incidences of Cu-pyropheophytin a presence, highlighting potential fraudulent practices within various oil products.
Aims: The aim of the present study was to compare the levels of stress, depression, and intention to leave among clinical nurses employed in different medical units in relation to their demographic characteristics under the National Health Insurance (NHI) System in Taiwan.
Methods: Cross-sectional Spearman's correlation, one-way ANOVA with Scheffe post hoc analysis tests, and multiple regression analyses were conducted. Several self-report questionnaires, such as the Center for Epidemiological Studies Depression Scale, the Perceived Stress Scale and Intention to Leave Scale, were administered.