Life cycle assessment of bamboo products: Review and harmonization.

Bamboo is considered a promising solution to mitigate climate change because of its carbon sequestration capability and versatile applications. Life cycle assessment (LCA) has been used to evaluate the environmental performance of various bamboo products. This study compared the Global Warming Potential (GWP) values of bamboo products with those of the corresponding benchmark materials (e.g., steel, concrete, plastics) through a comprehensive literature review of relevant LCA studies. The results showed that bamboo products often lead to lower GWP values. In several other cases, we also observed significant variability in the comparison results due to a wide range of assumptions regarding bamboo cultivation, processing, product manufacturing, energy supply, and choices of the LCA database adopted by the reviewed studies. We analyzed the key modeling assumptions for each life cycle stage of bamboo products and established a harmonized inventory dataset to reduce the uncertainty in modeling the processed bamboo (as a raw material for subsequently manufacturing various products). Based on the harmonized dataset, we conducted a cradle-to-gate LCA and concluded that the major contributor to the overall GWP result was electricity consumption (and associated carbon intensity of energy generation) during bamboo processing. We also concluded that future research was needed to improve the transparency, consistency, and comprehensiveness of LCA studies on bamboo products.

In vitro toxicity assessment of nanocrystals in tissue-type cells and macrophage cells.

Nanocrystals (NCs), a type of innovative material particle, are a potential drug delivery platform that aims to improve the bioavailability of hydrophobic drugs. However, due to the lack of consideration of their toxicity, existing studies have not investigated whether the nanoscale properties of NCs, such as particle sizes, may lead to NC-induced toxicity. Because of the disparity between the rapid development of NCs and the lack of studies regarding NC toxicity, the present study investigated possible NC toxicity and clarified the relationship between particle sizes and NC toxicity. RAW264.7 and HepG2 cells were chosen as representatives of macrophage cells and tissue-type cells, respectively. Monosodium urate NCs were used as a drug model. Different particle sizes of monosodium urate NCs were prepared using precipitation methods. Methyl tetrazolium, lactate dehydrogenase, oxidative stress and apoptosis/necrosis assays were then used to evaluate cell damage and recovery. The results showed that small NC particle sizes produced higher toxicity than larger ones. In immune cells, these cytotoxic effects were greater than in tissue cells. After removal of small NCs, tissue cell damage could be significantly reversed, while immune cells were only slightly restored. However, after removal of large NCs, both cell types had almost no recovery. In summary, despite conventional wisdom, our research confirmed that NCs are not very safe and that NC particle sizes are closely related to the degree of NC toxicity.

The Global Bioequivalence Harmonization Initiative: Summary report for EUFEPS international conference.

Bioequivalence (BE) is considered one of the key questions in new and generic drug product development and registration worldwide. However, the regulations and jurisdiction vary from country to country and continent to continent. Harmonization of regulatory requirements and criteria for BE determination may avoid unnecessary repetition of BE studies and minimize drug exposure to humans. Harmonization around the globe may be achieved by a better understanding of scientific principles and expectations from different regulatory authorities. To facilitate global harmonization, the Network on Bioavailability and Biopharmaceutics (BABP) under the European Federation for Pharmaceutical Sciences (EUFEPS) launched a Global Bioequivalence Harmonization Initiative (GBHI) several years ago. This international conference was the first in a series of workshops organized by EUFEPS/BABP under GBHI. The workshop provided a forum for pharmaceutical scientists from academia, industry and regulatory agencies to have open discussions on selected BE issues in the hope of identifying common ground and arriving at a harmonized view on these topics.

Development Considerations for Nanocrystal Drug Products.

Nanocrystal technology has emerged as a valuable tool for facilitating the delivery of poorly water-soluble active pharmaceutical ingredients (APIs) and enhancing API bioavailability. To date, the US Food and Drug Administration (FDA) has received over 80 applications for drug products containing nanocrystals. These products can be delivered by different routes of administration and are used in a variety of therapeutic areas. To aid in identifying key developmental considerations for these products, a retrospective analysis was performed on the submissions received by the FDA to date. Over 60% of the submissions were for the oral route of administration. Based on the Biopharmaceutics Classification System (BCS), most nanocrystal drugs submitted to the FDA are class II compounds that possess low aqueous solubility and high intestinal permeability. Impact of food on drug bioavailability was reduced for most nanocrystal formulations as compared with their micronized counterparts. For all routes of administration, dose proportionality was observed for some, but not all, nanocrystal products. Particular emphasis in the development of nanocrystal products was placed on the in-process tests and controls at critical manufacturing steps (such as milling process), mitigation and control of process-related impurities, and the stability of APIs or polymorphic form (s) during manufacturing and upon storage. This emphasis resulted in identifying challenges to the development of these products including accurate determination of particle size (distribution) of drug substance and/or nanocrystal colloidal dispersion, identification of polymorphic form (s), and establishment of drug substance/product specifications.

Harmonization of regulatory approaches for evaluating therapeutic equivalence and interchangeability of multisource drug products: workshop summary report.

Regulatory approaches for evaluating therapeutic equivalence of multisource (or generic) drug products vary among different countries and/or regions. Harmonization of these approaches may decrease the number of in vivo bioequivalence studies and avoid unnecessary drug exposure to humans. Global harmonization for regulatory requirements may be promoted by a better understanding of factors underlying product performance and expectations from different regulatory authorities. This workshop provided an opportunity for pharmaceutical scientists from academia, industry and regulatory agencies to have open discussions on current regulatory issues and industry practices, facilitating harmonization of regulatory approaches for establishing therapeutic equivalence and interchangeability of multisource drug products.

[Taiwan nursing student assessment of the value of a competence-based medical-surgical clinical performance examination model].

BACKGROUND: Assessment of nursing student abilities with regard to competent nursing practice has played an important role in the clinical nursing education revolution. PURPOSE: This study was designed to evaluate the value to Taiwanese BSN graduates of a competence-based clinical performance examination model for medical-surgical nursing. METHODS: Four semi-structured questions were used to explore the learning experience of 30 nursing students through their performance on a medical-surgical nursing clinical performance examination (CPE). Qualitative content analysis was used to identify categories. RESULTS: Differences found between the CPE and traditional clinical practicum included learning situation, learning process decision making procedures, and result evaluation procedures. Advantages of the CPE included confidence in self-competence, enhanced stimulation in clinical settings, self-directed learning, revised learning, and flexible learning. Disadvantages included poorer control over the overall learning process and less control of outcomes. Benefits to subjects from participating in the CPE included increased awareness, acceptance, and cultivation of self competence. A number of students expressed they perceived no specific benefits attributable to the CPE. CONCLUSION: Study findings are hoped to contribute to the development of the CPE in medical-surgical nursing in Taiwan.

Perceived uncertainty, social support and psychological adjustment in older patients with cancer being treated with surgery.

AIM: The purpose of this longitudinal correlative study was to explore the degree, compare the differences and to detect the relationships of uncertainty, social support and psychological adjustment for older cancer patients who were undergoing surgery. BACKGROUND: While the number of the older cancer patients has been increasing, there has been little research exploring their needs with respect to psychological adjustment during cancer treatment. DESIGN: The study used a pre-/postdescriptive design. METHODS: Purposive sampling was used to recruit 43 patients aged 65-84 from six surgery wards in a medical centre in northern Taiwan from January 2005-May 2005. Participants were interviewed one to two days prior to surgery and interviewed again one to two days before hospital discharge. Demographic data, Mishel's Uncertainty Illness Scale, Hospital Anxiety and Depression Scale and the Interpersonal Support Evaluation List were used to collect data. RESULTS: Uncertainty varied with cancer stage. At the time of surgery, the patients had moderate levels of uncertainty. There was a significant decrease in uncertainty at the second data collection period before hospital discharge. In these participants, anxiety was significantly associated with past medical history. The participants obtained social support from family members, physicians, nurses, relatives and other patients. Married patients had higher levels of social support than those without a spouse. Significant relationships were found among uncertainty and anxiety and depression. Interestingly, a positive relationship between anxiety and social support after surgery was also identified. CONCLUSION: Increasing levels of social support could ameliorate the degree of uncertainty, anxiety and depression in older cancer patients. Nurses should provide resources to establish an effective social network to older cancer patients who were being treated surgically. RELEVANCE TO CLINICAL PRACTICE: These findings can assist nurses in understanding the psychological adjustment needs among older cancer patients who were undergoing surgery and provide appropriate intervention in nursing care.

Validation of the Taiwanese version of the Brief Fatigue Inventory.

We validated the Taiwanese version of the Brief Fatigue Inventory (BFI-T) in a sample of 439 Taiwanese patients with multiple cancer diagnoses. Internal consistency was indicated by Cronbach alphas of 0.96 for fatigue-related severity and 0.95 for interference. Test-retest reliability was 0.89 for fatigue severity and 0.91 for interference. Factor analysis revealed a one-factor structure. Convergent validity was examined by correlating the BFI-T worst fatigue and fatigue severity composite scores with POMS vigor and fatigue subscales scores. Known-group validity was established by comparing BFI-T worst fatigue and severity composite scores between patients with low functional status and high functional status and between inpatients and outpatients. The BFI-T's sensitivity was examined by comparing BFI-T severity and interference composite scores before, during, and after chemotherapy treatment in a subsample of 20 breast cancer patients. The BFI-T is reliable, valid, and sensitive for measuring cancer-related fatigue severity and interference among Taiwanese cancer patients.

Assuring quality and performance of sustained and controlled release parenterals: EUFEPS workshop report.

This is a summary report of the workshop, organized by the European Federation of Pharmaceutical Scientists in association with the American Association of Pharmaceutical Scientists, the European Agency for the Evaluation of Medicinal Products, the European Pharmacopoeia, the US Food and Drug Administration and the United States Pharmacopoeia, on "Assuring Quality and Performance of Sustained and Controlled Release Parenterals" held in Basel, Switzerland, February 2003. Experts from the pharmaceutical industry, regulatory authorities and academia participated in this workshop to review, discuss and debate formulation, processing and manufacture of sustained and controlled release parenterals, and identify critical process parameters and their control. This workshop was a follow-up workshop to a previous workshop on Assuring Quality and Performance of Sustained and Controlled Release Parenterals that was held in Washington, DC in April 2001. This report reflects the outcome of the Basel 2003 meeting and the advances in the field since the Washington, DC meeting in 2001. As necessary, the reader is referred to the report on the 2001 meeting. Areas were identified at the 2003 Basel meeting where research is needed in order to understand the performance of these drug delivery systems and to assist in the development of appropriate testing procedures. Recommendations were made for future workshops and meetings.

Assuring quality and performance of sustained and controlled release parenterals: AAPS workshop report, co-sponsored by FDA and USP.

This is a summary report of the American Association of Pharmaceutical Scientists, the Food and Drug Administration, and the United States Pharmacopoeia cosponsored workshop on "Assuring Quality and Performance of Sustained and Controlled Release Parenterals." Experts from the pharmaceutical industry, the regulatory authorities, and academia participated in this workshop to review, discuss, and debate formulation, processing, and manufacture of sustained and controlled release parenterals and identify critical process parameters and their control. Areas were identified where research is needed to understand the performance of these drug delivery systems and to assist in the development of appropriate testing procedures. Recommendations were made for future workshops, meetings, and working groups in this area.