Quality by design (QbD) and process analytical technology (PAT) applications in pharmaceutical industry

Quality by Design (QbD) for the pharmaceutical industry includes the design, development and production control of products and production processes from the beginning to the end of the product development phase for ensuring the consistent quality of a pharmaceutical product. The QbD is a systematic scientific approach aimed at meeting the needs of the patient in the desired and targeted quality and aiming to produce the same quality pharmaceutical product in this direction. Process Analytical Technology, which is assessed in that regard, is part of a design quality approach that is used to design, analyze, and control real-time measurements of quality and performance criteria for raw and processed materials to achieve the desired final product. This scientific and systematic approach to pharmaceutical product development, which is also acknowledged and supported by the health authorities, serves to the changing and developing pharmaceutical sector

Effectiveness of the reserve option mechanism as a macroeconomic prudential tool: evidence from Turkey

This article assesses the effectiveness of a novel macroprudential tool – the reserve option mechanism (ROM) – which Turkey’s central bank developed during the post-2008 period and has employed to control the risk associated with excessive capital flows. We assess how capital flows have affected economic variable changes since the introduction and usage of the ROM. Empirical evidence gathered from Turkey suggests that the tool decreases the effect of capital flow on capital flow (positive shock to capital flow dies out faster or becomes less persistent) and diminishes the effects of capital flow shocks on exchange and interest rates. © 2015 Taylor & Francis

Short Communication Effects of short chain fatty acid (SCFA) supplementation on performance and egg characteristics of old breeder hens

A study was conducted to determine the effect of supplementing the diet of breeder hens with a short-chain fatty acid (SCFA) premix, containing 509 g fatty acid salts/kg of which 285 g were calcium butyrate, on their eggshell characteristics and the hatching percentage of the eggs. One thousand six hundred 66-week old White Bovans laying breeder hens were used in this experiment. They were housed in eight identical pens, each containing 200 birds, and four pens were used per treatment. The SCFA premix was included at 1000 mg/kg in the treatment diet, and fed for a period of nine weeks. Responses were compared with an unsupplemented treatment. Supplementation started when the hens were 66 weeks old. From day 75 eggs were collected for the next seven weeks and the occurrence of cracked, dirty and misshapen eggs was recorded, and the hatching percentage of the eggs was determined. Eggshell strength was lower in eggs from the control (1.76 ± 0.05) than from the treatment group (2.07 ± 0.03). The percentage of eggs produced by the control group (68.6 ± 0.08) was significantly lower than that by the supplemented group (71.5 ± 0.15). Percentage of dirty, cracked and misshapen eggs, and the hatchability percentage of the control group (1.15 ± 0.03, 3.44 ± 0.05, 6.27 ± 0.03 and 88.93 ± 0.06, respectively) were also significantly lower than in the group receiving SCFA (0.47 ± 0.03, 2.21 ± 0.03, 3.81 ± 0.03 and 93.36 ± 0.05, respectively). It was concluded that dietary supplementation of SCFA to layer breeder hens from 66 weeks of age onwards improved eggshell strength, reduced the percentage of dirty, cracked and misshapen eggs and increased the hatching percentage of the eggs. The positive responses were suggested to be largely due to the butyrate in the SCFA. Keywords: Butyrate; SCFA; eggshell quality; hatching characteristics South African Journal of Animal Science Vol. 37 (3) 2007: pp.158-16

Assessment of relationship between pain, psychological status, quality of life and body mass index

Objective: The purpose of the study is to evaluate health-related quality of life (HRQL), pain, the number of painful areas, and depression level; both to compare obesity level and these parameters, and to compare between obese and non-obese participants. Materials (Subjects) and Methods: 1875 voluntary patients were evaluated. Patients were grouped into 5 according to body mass index (BMI) values: Group 1:17-24.99kg/m2, Group 2:25-29.99kg/m2, Group 3:30-34.99kg/m2, Group 4:35-35.99kg/m2, Group 5: BMI more than 40kg/m2. Patients were asked to fulfill a questionnaire about demographic data and a number of painful areas (neck, shoulder, elbow, wrist, back, low back, knee, ankle, and temporomandibular joint). All patients were evaluated with visual analog scale (VAS), for pain, short form-36 (SF-36) for HRQL, Beck Depression Scale (BDS) for depression level. Results:We have included 1832 patients (460 male, and 1372 female) in the study: Group 1: 285(16%), Group 2: 623(34%), Group 3: 653(36%), Group 4: 190(10%), Group 5: 81(4%). When the groups was compared according to VAS scores during activity; all other groups was higher than group 1 (p<0.01). When the BDS scores were compared; depression levels were higher in group 5 than the other groups. When a number of painful areas were compared; groups 3,4,5 had higher values than groups 1,2, and group 2 had higher values than group 1 (p<0.001). Conclusion: This study evaluates pain level, the number of painful areas, physical HRQL, and depression levels of pre-obese and obese patients using VAS, BDS, and SF-36 scores and proves negative effects when compared to the healthy population. But this effect does not correlate with BMI levels.Objective: The purpose of the study is to evaluate health-related quality of life (HRQL), pain, the number of painful areas, and depression level; both to compare obesity level and these parameters, and to compare between obese and non-obese participants. Materials (Subjects) and Methods: 1875 voluntary patients were evaluated. Patients were grouped into 5 according to body mass index (BMI) values: Group 1:17-24.99kg/m2, Group 2:25-29.99kg/m2, Group 3:30-34.99kg/m2, Group 4:35-35.99kg/m2, Group 5: BMI more than 40kg/m2. Patients were asked to fulfill a questionnaire about demographic data and a number of painful areas (neck, shoulder, elbow, wrist, back, low back, knee, ankle, and temporomandibular joint). All patients were evaluated with visual analog scale (VAS), for pain, short form-36 (SF-36) for HRQL, Beck Depression Scale (BDS) for depression level. Results:We have included 1832 patients (460 male, and 1372 female) in the study: Group 1: 285(16%), Group 2: 623(34%), Group 3: 653(36%), Group 4: 190(10%), Group 5: 81(4%). When the groups was compared according to VAS scores during activity; all other groups was higher than group 1 (p<0.01). When the BDS scores were compared; depression levels were higher in group 5 than the other groups. When a number of painful areas were compared; groups 3,4,5 had higher values than groups 1,2, and group 2 had higher values than group 1 (p<0.001). Conclusion: This study evaluates pain level, the number of painful areas, physical HRQL, and depression levels of pre-obese and obese patients using VAS, BDS, and SF-36 scores and proves negative effects when compared to the healthy population. But this effect does not correlate with BMI levels

Profile differences of medical doctors from three different hospitals in Turkey concerning burnout, job satisfaction, and depression

Objective: This study aimed to compare job satisfaction, burnout, and depression scores of medical doctors from different regions in Turkey. Method: A cross-sectional study was performed during October 2013 in three cities from Turkey. Participants were asked to self-administer a demographic information questionnaire, the Minnesota Satisfaction Questionnaire (Internal work satisfactionIWS and External work satisfaction-EWS), the Beck Depression Inventory (BDI), the Maslach Burnout Inventory (MBI), Maslach Emotional Exhaustion Score (MEES), and Maslach Personal Accomplishment Score (MPAS). Results: Mean (±SD) Total work satisfaction score was 66.2±12.6. 118 participants had BDI scores of 10 or less while 40 participants had 11 or higher scores. Proportions for poor depersonalization, emotional exhaustion, and personal accomplishment were 18.6% (n=29), 5.8% (n=9), and 81.9% (n=127) respectively. There were significant differences concerning some variables between the three cities. Most of the doctors in Şırnak and Hakkari were younger, single, and less experienced compared to the more developed Çanakkale (p<0.05). Discussion: In a hierarchical regression analysis, independent of the other factors, MPAS and MEES were predictors of the total job satisfaction score. MPAS and MEES are the most significant independent variables affecting job satisfaction. Decreasing stressors and assuring a motivating and supportive environment may prove to be helpful in the enhancement of job satisfaction

Improved arterial stiffness in mitral stenosis after successful percutaneous balloon valvuloplasty

Background: Rheumatic mitral stenosis (MS) is still a common disease in developing countries with high morbidity and mortality rates. The purpose of the study was to evaluate arterial stiffness in severe MS before and after percutaneous mitral balloon valvuloplasty (PMBV). Methods: Thirty patients with MS in sinus rhythm requiring PMBV and 20 age-gender matched healthy volunteers. The analyze of pulse wave velocities (PWV) were performed using of the carotid artery at the femoral by PWV technique on patients at baseline and a week after PMBV. Results: The values of PWV were significantly decreased after successful PMBW in MS patients. Mitral mean gradients and systolic pulmonary artery pressures (sPAP) both on echocardiography and catheterization also had a significant decrease after PMBW. The mitral valve areas were significantly increased after PMBW. There was a highly significant negative correlation between mitral valve areas and PWV values. A highly significant positive correlation was seen between mitral mean gradient on catheterization and PWV (r = 0.830, p < 0.001). There was also a significant correlation between sPAP on catheterization and PWV values (r = 0.639, p < 0.001). Echocardiographic mitral mean gradients and PWV were highly positive correlated with each other (r = 0.841, p < 0.001). The sPAP on echocardiography had also a highly positive correlation with PWV (r = 0.681, p < 0.001). Conclusions: Mitral stenosis is a cause of impaired arterial stiffness and after the enlargened mitral valve area arterial stiffness improved in patients with MS