Quality Risk Management-A Role-Based Competency Model.

In collaboration with the Pharmaceutical Regulatory Science Team (PRST), a research team based at the Technological University Dublin (TU Dublin) in Ireland, a research study exploring the need for developing quality risk management (QRM) role-based competencies as fundamental elements to realizing QRM's benefits was conducted. The research study followed a hybrid Delphi research methodology of which elements are presented in the paper titled "Quality Risk Management Competency Model-Case for the need for QRM Competencies." This paper presents the second part of the Delphi research methodology, focusing on the results of a detailed technical and behavioral competencies questionnaire and a proposed QRM role-based competency model.

HPLC method transfer study for simultaneous determination of seven angiotensin II receptor blockers.

In this study, a sensitive high-performance liquid chromatography method was developed and validated for the simultaneous determination of seven angiotensin II receptor blockers, namely, hydrochlorothiazide, chlorthalidone, eprosartan mesylate, valsartan, losartan potassium, irbesartan, and candesartan cilexetil. Different chromatographic parameters were tested and fully optimized. Best chromatographic separation was accomplished on a reversed-phase octadecylsilyl column (250 × 4.6 mm id; 5 µm) under gradient elution using methanol/sodium phosphate monobasic buffer (0.01 M, pH 6.5) as mobile phase. The detection of target analytes was obtained at 254 nm. The pH of the buffer has been selected according to Marvin® sketch software. The proposed method was validated according to ICH guidelines and showed good precision (relative standard deviation < 1), good linearity (square of correlation coefficient ≥ 0.999), and high accuracy (between 98 and 102%) with detection limit and quantitation limit (40 and 160 ng/mL, respectively) for all the detected analytes.

Quality Risk Management - A Role-Based Competency Model.

In collaboration with the Pharmaceutical Regulatory Science Team (PRST), a research team based at the Technological University Dublin (TU Dublin) in Ireland, a research study exploring the need for developing QRM role-based competencies, as fundamental elements to realizing Quality Risk Management 's benefits was conducted. The research study followed a hybrid Delphi research methodology of which elements are presented in paper titled ″Quality Risk Management Competency Model- Case for the need for QRM Competencies.″ This paper presents the second part of the Delphi research methodology, focusing on the results of a detailed technical and behavioral competencies questionnaire and a proposed QRM role-based competency model.

Armed conflicts and national trends in reproductive, maternal, newborn and child health in sub-Saharan Africa: what can national health surveys tell us?

Armed conflicts are widespread in sub-Saharan Africa and considered to be an important factor in slowing down national progress in reproductive, maternal, newborn and child health (RMNCH). The measurement of the impact of conflicts on national levels and trends in RMNCH is difficult. National surveys conducted before and sometimes during and after conflicts are a major source of information on the national and local effects of conflicts on RMNCH. We examined data from national surveys in 13 countries in sub-Saharan Africa with major conflicts during 1990-2016 to assess the levels and trends in RMNCH intervention coverage, nutritional status and mortality in children under 5 years in comparison with subregional trends. The surveys provide substantive evidence of a negative association between levels and trends in national indicators of RMNCH service coverage, child growth and under-5 mortality with armed conflict, with some notable exceptions. National surveys are an important source of data to assess the longer term national consequences of conflicts for RMNCH in most countries, despite limitations due to sampling and timing of the surveys.

Quality Risk Management Competency Model-Case for the Need for QRM Competencies.

The Pharmaceutical Regulatory Science Team (PRST), a research team based at the Dublin Technological University (TU Dublin) in Ireland, recently conducted a Quality Risk Management (QRM) survey and a face-to-face focus group workshop to assess the level of formality of QRM roles in the biopharmaceutical sector. This was carried out as part of a research study, which identified the need for the development of QRM role-based competencies as fundamental to realizing QRM's benefits. The research study followed a hybrid Delphi research methodology composed of: (1) Survey 1, (2) focus group workshop, (3) Survey 2, and (4) competency model development. This paper presents the results of Survey 1 and the focus group workshop. Survey 1 explored the need for QRM role-based competencies and the subsequent face-to-face focus group workshop built on this to propose initial standard QRM roles, with a view to confirming these and developing associated competencies. This paper presents the findings from Survey 1 and the focus group workshop. The results of the follow-up research activities will be presented in a subsequent paper.LAY ABSTRACT: The publication of the ICH Q9 Quality Risk Management (QRM) guideline in 2005 has greatly impacted the biopharmaceutical sector. Fourteen years after Q9, the benefits of QRM are yet to be realized. The biopharmaceutical sector still struggles with the implementation of Q9 principles to effectively assess and manage product quality risks as a surrogate for patient safety.This paper looks at the need for standard QRM roles and the associated competencies for those roles.

Comparative Randomized Crossover Clinical Study for the Evaluation of Erectile Dysfunction Medications Via Novel Pentagon System.

INTRODUCTION: Due to the chaos in the legislation in the Middle East, male enhancement nutraceuticals may be sold without any registration or evaluation. These products need to be evaluated with respect to safety and efficacy. Furthermore, cultural and social considerations in the Middle East prevent the use of international evaluations schemes for erectile dysfunction. AIM: Evaluating the safety and efficacy parameters of generic and nutraceutical products for erectile dysfunction in the Middle East through a custom-designed, representable and simple system tailored to the regional culture. METHODS: 74 healthy male volunteers were enrolled into a comparative, simple randomized, single dose, double blind, and crossover clinical study incorporated with a tailored-designed questionnaire. Safety assessment included laboratory analysis for liver functions and measuring blood pressure. MAIN OUTCOME MEASURES: Subjective data regarding safety and efficacy were assessed from the validated questionnaire. Blood pressure was measured. Blood samples were collected to assess the drug/adulterants concentration and liver and kidney functions. RESULTS: All tested nutraceuticals showed undeclared Sildenafil citrate in patients. Questionnaire results showed high inter-patient variability with respect to efficacy and comparable safety profile compared to Viagra®. CONCLUSION: The validated tailored-designed questionnaire effectively assessed the efficacy and safety of male enhancement products. The male enhancement nutraceuticals, sold in Egypt, claimed to be 100% natural are adulterated and of questionable safety profile.

Patterns and determinants of antenatal care utilization: analysis of national survey data in seven countdown countries.

BACKGROUND: Antenatal care (ANC) is critical for improving maternal and newborn health. WHO recommends that pregnant women complete at least four ANC visits. Countdown and other global monitoring efforts track the proportions of women who receive one or more visits by a skilled provider (ANC1+) and four or more visits by any provider (ANC4+). This study investigates patterns of drop-off in use between ANC1+ and ANC4+, and explores inequalities in women's use of ANC services. It also identifies determinants of utilization and describes countries' ANC-related policies, and programs. METHODS: We performed secondary analyses using Demographic Health Survey (DHS) data from seven Countdown countries: Bangladesh, Cambodia, Cameroon, Nepal, Peru, Senegal and Uganda. The descriptive analysis illustrates country variations in the frequency of visits by provider type, content, and by household wealth, women's education and type of residence. We conducted a multivariable analysis using a conceptual framework to identify determinants of ANC utilization. We collected contextual information from countries through a standard questionnaire completed by country-based informants. RESULTS: Each country had a unique pattern of ANC utilization in terms of coverage, inequality and the extent to which predictors affected the frequency of visits. Nevertheless, common patterns arise. Women having four or more visits usually saw a skilled provider at least once, and received more evidence-based content interventions than women reporting fewer than four visits. A considerable proportion of women reporting four or more visits did not report receiving the essential interventions. Large disparities exist in ANC use by household wealth, women's education and residence area; and are wider for a larger number of visits. The multivariable analyses of two models in each country showed that determinants had different effects on the dependent variable in each model. Overall, strong predictors of ANC initiation and having a higher frequency (4+) of visits were woman's education and household wealth. Gestational age at first visit, birth rank and preceding birth interval were generally negatively associated with initiating visits and with having four or more visits. Information on country policies and programs were somewhat informative in understanding the utilization patterns across the countries, although timing of adoption and actual implementation make direct linkages impossible to verify. CONCLUSION: Secondary analyses provided a more detailed picture of ANC utilization patterns in the seven countries. While coverage levels differ by country and sub-groups, all countries can benefit from specific in-country assessments to properly identify the underserved women and the reasons behind low coverage and missed interventions. Overall, emphasis needs to be put on assessing the quality of care offered and identifying women's perception to the care as well as the barriers hindering utilization. Country policies and programs need to be reviewed, evaluated and/or implemented properly to ensure that women receive the recommended number of ANC visits with appropriate content, especially, poor and less educated women residing in rural areas.

A cross sectional study of maternal 'near-miss' cases in major public hospitals in Egypt, Lebanon, Palestine and Syria.

BACKGROUND: The maternal near-miss approach has been increasingly used as a tool to evaluate and improve the quality of care in maternal health. We report findings from the formative stage of a World Health Organization (WHO) funded implementation research study that was undertaken to collect primary data at the facility level on the prevalence, characteristics, and management of maternal near-miss cases in four major public referral hospitals - one each in Egypt, Lebanon, Palestine and Syria. METHODS: We conducted a cross sectional study of maternal near-miss cases in the four contexts beginning in 2011, where we collected data on severe maternal morbidity in the four study hospitals, using the WHO form (Individual Form HRP A65661). In each hospital, a research team including trained hospital healthcare providers carried out the data collection. RESULTS: A total of 9,063 live birth deliveries were reported during the data collection period across the four settings, with a total of 77 cases of severe maternal outcomes (71 maternal near-miss cases and 6 maternal deaths). Higher indices for the maternal mortality index were found in both Al Galaa hospital, in Egypt (8.6%) and Dar Al Tawleed hospital in Syria (14.3%), being large referral hospitals, compared to Ramallah hospital in Palestine and Rafik Hariri University hospital in Lebanon. Compared to the WHO's Multicountry Survey using the same data collection tool, our study's mortality indices are higher than the index of 5.6% among countries with a moderate maternal mortality ratio in the WHO Survey. Overall, haemorrhage-related complications were the most frequent conditions among maternal near-miss cases across the four study hospitals. In all hospitals, coagulation dysfunctions (76.1%) were the most prevalent dysfunction among maternal near-miss cases, followed by cardiovascular dysfunctions. The coverage of key evidence-based interventions among women experiencing a near-miss was either universal or very high in the study hospitals. CONCLUSIONS: Findings from this formative stage confirmed the need for quality improvement interventions. The high reported coverage of the main clinical interventions in the study hospitals would appear to be in contradiction with the above findings as the level of coverage of key evidence-based interventions was high.

Development of a fast high performance liquid chromatographic screening system for eight antidiabetic drugs by an improved methodology of in-silico robustness simulation.

Robustness of RP-HPLC methods is a crucial method quality attribute which has gained an increasing interest throughout the efforts to apply quality by design concepts in analytical methodology. Improvement to design space modeling approaches to represent method robustness was the goal of many previous works. Modeling of design spaces regarding to method robustness fulfils quality by design essence of ensuring method validity throughout the design space. The current work aimed to describe an improvement to robustness modeling of design spaces in context of RP-HPLC method development for screening of eight antidiabetic drugs. The described improvement consisted of in-silico simulation of practical robustness testing procedures thus had the advantage of modeling design spaces with higher confidence in estimated of method robustness. The proposed in-silico robustness test was performed as a full factorial design of simulated method conditions deliberate shifts for each predicted point in knowledge space with modeling error propagation. Design space was then calculated as zones exceeding a threshold probability to pass the simulated robustness testing. Potential design spaces were mapped for three different stationary phases as a function of gradient elution parameters, pH and ternary solvent ratio. A robust and fast separation for the eight compounds within less than 6 min was selected and confirmed through experimental robustness testing. The effectiveness of this approach regarding definition of design spaces with ensured robustness and desired objectives was demonstrated.

Extrapulmonary small cell: a novel case of small cell carcinoma of the thyroid gland.

Neuroendocrine tumors comprise a large group of malignancies which share unique morphological features and are characterized by the presence of neuroendocrine markers such as synaptophysin, chromogranin-A, and CD56 (N-CAM), ranging from indolent tumors, such as carcinoid tumors, to aggressive tumors, such as small cell carcinoma. The lung is the most common site for primary neuroendocrine tumors. Extrapulmonary primary sites of small cell carcinoma are rare but have been documented arising from various sites including esophagus, stomach, colon and rectum, gallbladder, thymus, salivary gland, ovary, cervix, bladder, prostate, and skin. We present a case of small cell carcinoma arising from the thyroid gland, a site not previously described in the literature. A 59-year-old woman presented with a thyroid mass, which, after resection, showed small cell morphology and positive immunostains for TTF-1, synaptophysin, chromogranin-A, CD56, etc. Five months after diagnosis, she had widely metastatic disease. After a near-complete response to the first chemo-treatment, her disease progressed. Following local radiation and more rounds of chemotherapy, she succumbed to the disease, 15 months after diagnosis. Our patient had no pulmonary lesions at the time of diagnosis to suggest metastasis from the lung. Much like its pulmonary counterparts, this small cell carcinoma of primary thyroid origin displayed an aggressive clinical course and poor outcome. Although it shows early sensitivity to chemotherapy, small cell carcinoma remains a difficult-to-treat cancer with a poor prognosis and can rarely be seen originating in organs outside of the lung.