Electron Crystallographic Analysis of Deposits on the Mesostructural Scale

Accuracy is addressed by implementation of instrument calibration or/and method control. Precision is required either in suitability verification or performed when testing the samples. Here the approaches of suitability verifications and scientific rationales for compendial methods are presented for Visible Particulates, Sub-Vis Particles, pH, Osmolality, Color and Clarity/Opalescence. Current challenges and recommendations are also discussed for each method. Copyright © 2020, Parenteral Drug Association.Chemistry, Manufacturing and Control Post-Approval Changes are an intrinsic part of the lifecycle of pharmaceutical products. In this paper, the authors examine the potential impact of such changes on product quality, safety and efficacy of biologics. Comparability studies and more specifically analytical comparability are introduced as one of the tools that can support both biomanufacturers and health agencies in ensuring that patient safety, product safety and efficacy is maintained through the proposed changes. dTAG-13 FKBP chemical Together with a scientific risk-based review approach based on product and process knowledge and the definition of acceptance criteria that will ensure that the product is 'essentially similar', what constitutes a holistic comparability study is detailed. ICH Guidelines principles and definitions are used throughout the paper to aid the reader with other appropriate references. Finally, three case studies are presented change to the manufacturing facility of the drug substance, change to the manufacturing process of a drug substance intermediate and manufacturing facility, and justification of not including drug product in analytical compatibility. Copyright © 2020, Parenteral Drug Association.It is generally acknowledged that quantitation in extractables and leachables (E&L) can be variably reproducible and accurate, depending on the quantitation approach taken. This is especially true for ″simple″ quantitation, which is the practice of estimating an analyte's concentration based on its response relative to that of an internal standard which has been added to the sample in a known amount. Simple quantitation is prone to error and variation as it is based on the largely false premise that the response factors for all extractables, leachables and internal standard candidates are the same. It has been proposed that this uncertainty (inaccuracy and variation) be accounted for by adjusting two key parameters in E&L assessment, the reported concentrations themselves and the Analytical Evaluation Threshold (AET) via an Uncertainty Factor (UF). This Correspondence examines quantitation variation, and discusses the means of establishing and utilizing the UF to adjust the AET to lower values and adjust reported concentrations to higher values, enabling an impact assessment performed with this data to be more protective of patient safety. Although adjustment of the AET lower with the UF is supported, flaws in the concept of using the UF to adjust reported concentration upward are considered and it is recommended that the UF not be used in this manner. Rather, E&L quantitation should be based on compound-specific relative response factors, collected and collated in an E&L database. Copyright © 2020, Parenteral Drug Association.BACKGROUND AND PURPOSE Conflicts in nursing workplace are frequent and can be resolved by individuals or groups. The purpose of this study was to develop a valid and reliable measure for the Workplace Conflicts among Emergency Department Nurses (WCEDN). METHODS A three-stage mixed methods study was conducted (a) In-depth interviews with emergency department (ED) nurses were performed and themes were extracted from the data (b) Findings of the content analysis in combination with results of a literature review were examined, and preliminary instrument items were developed. The initial instrument comprised 50 items. (c) Content validity, face validity, content validity ratio, content validity index, and construct validity using exploratory factor analysis were performed. RESULTS Subscales in the final instrument included Intrapersonal Conflict, Intragroup Conflict, Intergroup Conflict, and Causes of Conflict. Reliability of the instrument was .86, and the feasibility was 96.8%. CONCLUSIONS The final 40-item WCEDN demonstrated strong psychometric properties. © Copyright 2020 Springer Publishing Company, LLC.BACKGROUND AND PURPOSE Trauma-informed care (TIC) acknowledges the lasting effects of trauma on individuals. The Attitudes Related to Trauma-Informed Care (ARTIC-35) scale was developed to examine healthcare providers' attitudes related to TIC. Here, we present an item-level analysis of the ARTIC-35 scale for use with nurses and compare our findings to the current ARTIC-35 structure. METHODS Principal components analysis, qualitative inter-item analysis, and qualitative intra-item analysis of the ARTIC-35. FINDINGS Our principal component analysis structure supported a nine-factor solution, inter-item qualitative analysis structure supported five subscales, and intra-item qualitative analysis identified 13 acceptable items and 22 items requiring revision for use with nurses. DISCUSSION When used with nurses, there are important considerations regarding scale validity and challenges with the design of the original ARTIC-35 scale. © Copyright 2020 Springer Publishing Company, LLC.BACKGROUND AND PURPOSE The Health Risk Screening Tool (HRST) is a 22-item instrument specifically designed to assess the health risk of persons with developmental disabilities. The predictive validity of the HRST was investigated by examining its ability to predict mortality. METHODS The sample consisted of 12,582 people with an intellectual or developmental disability residing in Georgia (U.S.). Data were analyzed using survival analysis (Kaplan-Meier estimate and Cox regression) and a binary logistic regression. RESULTS All models supported the prognostic value of the six-level health risk classification. The Kaplan-Meier procedure showed clear separation among functions. The Cox proportional hazard regression revealed that hazard is inversely related to the health risk level, even after controlling for potential confounding by gender, ethnicity, and race. CONCLUSIONS The HRST can predict mortality. Therefore, it can serve as a basis for establishing healthcare needs and determining nursing care acuity. © Copyright 2020 Springer Publishing Company, LLC.