QbD Implementation in Biotechnological Product Development Studies

Biotechnological drug development is an extensive area still growing and coming into prominence day by day. Since biotechnological product manufacturing is irreversible, highly expensive, and contains so many critical parameters throughout the process, quality control tests applied to the finished product become inefficacious; therefore, maintaining predefined quality is crucial. Quality by Design (QbD), a systematic approach, is designing and optimizing of formulation and production processes in order to provide a predefined product quality by following a risk and scientific-based path. Determining the critical variables for biotechnological products and their manufacturing via risk assessment is the first and most vital stage of QbD approach, before exploring the multivariate relations among the independent and dependent critical variables by mathematical modeling with the assistive technologies. Response Surface Method (RSM), Artificial Neural Network (ANN), and Genetic Algorithm (GA) are some of the assistive technologies used to perform mathematical modeling. After modeling, additional knowledge is vested and this provides the chance to find a range in which the product quality is always ensured, called as “Design space”. So, product quality is procured all along the process by keeping the critical variables under control with less effort, money, and mistakes

Why do psychiatrists commit suicide? Denial or stigma?

INTRODUCTION: Suicide is a complicated public health issue. Despite the expectation that psychiatrists have the most knowledge of suicide from a biopsychosocial perspective, there are few studies assessing the mental health and suicide rates of psychiatrists.This study aims to assess the suicide-related attitudes and behaviors of mental health professionals, as well as the stigma associated with suicide. METHODS: This cross-sectional survey was conducted with psychiatrists (resident in psychiatry and specialist) in Turkey. An online survey was created via the Google Forms public web address. Online questionnaires were delivered through Google Forms by emailing and messaging on WhatsApp, Telegram, Google and Yahoo groups.The study was performed between November 23, 2022 and February 23, 2023. The Socio-demographic Information Form and the Stigma of Suicide Scale (SOSS) were used to evaluate the participants. RESULTS: 225 psychiatrists participated in the study. All participants reported low levels of stigmatization related to suicide. Assistant physicians had significantly higher scores in the elevation/norming subscale compared to specialist physicians (p=0.018). Participants who believe in a religion received significantly higher scores in the stigmatization and isolation/depression subscales compared to those who do not believe (p=0.006, p=0.003, respectively). Participants without a history of suicidal ideation received significantly higher scores in the stigmatization subscale compared to those who have had suicidal ideation (p=0.004). DISCUSSION AND CONCLUSION: Although the stigma scores related to suicide reported by the participants were low, we know that the suicide rates among psychiatrists are high. Psychiatrists may hide, deny, and rationalize their feelings, thoughts, and beliefs about suicide

Quality by design approach for tablet formulations containing spray coated ramipril by using artificial intelligence techniques

Different software programs based on mathematical models have been developed to aid the product development process. Recent developments in mathematics and computer science have resulted in new programs based on artificial neural networks (ANN) techniques. These programs have been used to develop and formulate pharmaceutical products. In this study, intelligent software was used to predict the relationship between the materials that were used in tablet formulation and the tablet specifications and to determine highly detailed information about the interactions between the formulation parameters and the specifications. The input data were generated from historical data and the results obtained from analyzing tablets produced by different formulations. The relative significance of inputs on various outputs such as assay, dissolution in 30 min and crushing strengths, was investigated using the artificial neural networks (ANNs), neurofuzzy logic and genetic programming (FormRules, INForm ANN and GEP).This study indicated that ANN and GEP can be used effectively for optimizing formulations and that GEP can be evaluated statistically because of the openness of its equations. Additionally, FormRules was very helpful for teasing out the relationships between the inputs (formulation variables) and the outputs

Quality by design approach for tablet formulations containing spray coated ramipril by using artificial intelligence techniques

Different software programs based on mathematical models have been developed to aid the product development process. Recent developments in mathematics and computer science have resulted in new programs based on artificial neural networks (ANN) techniques. These programs have been used to develop and formulate pharmaceutical products. In this study, intelligent software was used to predict the relationship between the materials that were used in tablet formulation and the tablet specifications and to determine highly detailed information about the interactions between the formulation parameters and the specifications. The input data were generated from historical data and the results obtained from analyzing tablets produced by different formulations. The relative significance of inputs on various outputs such as assay, dissolution in 30 min and crushing strengths, was investigated using the artificial neural networks (ANNs), neurofuzzy logic and genetic programming (FormRules, INForm ANN and GEP).This study indicated that ANN and GEP can be used effectively for optimizing formulations and that GEP can be evaluated statistically because of the openness of its equations. Additionally, FormRules was very helpful for teasing out the relationships between the inputs (formulation variables) and the outputs

Quality by design (QbD) for pharmaceutical area

Recent changes and limited resources for drug development and manufacturing have rendered the conventional pharmaceutical quality assurance approach insufficient and have given rise to new research in these areas. To address these research efforts, the FDA improved and modernized the rules governing pharmaceutical manufacturing and product quality in 2002, thereby realizing a paradigm change in the current Good Manufacturing Practices (cGMP). The Quality by Design (QbD) approach has entered the pharmaceutical industry within the last 10 years after the approval of the ICH Q8 in 2005. QbD is based on an understanding of the target product's quality profile (QTPP) and an assessment of its risks during the design and development of pharmaceutical dosage forms. By determining the critical quality attributes of the drug, including its active ingredient, its excipients, and the processes and design spaces used during the R&D phase, multi-way tracking during the life cycle of the drug can be achieved. This tracking can provide numerous advantages, including flexibility in licensing by decreasing the variation and type modifications in applications of the pharmaceutical product, which result from minimizing the possible issues arising after the release of the product. When all these data are observed, it is clear that the new QbD approach benefits the authorities, the drug manufacturers and the patient. Although QbD has certain challenges during its early stages, it is thought that QbD will benefit pharmaceutical manufacturers

WOMAN DURING THE DIVORCE PROCESS AND AFTER

Boşanma, evlilik kurumundan beklentilerini karşılayamayan çiftlerin yasal yollara başvurarak evlilik kurumunu sonlandırması durumudur. Boşanma sürecinde ve sonrasında erkeklere oranla daha çok zarar gören taraf kadınlar olmaktadır. Bu çalışmada on tane boşanmış kadın ile derinlemesine görüşme tekniği kullanılarak görüşülmüş, boşanma kararını verirken onları etkileyen faktörlere ve boşanma sürecinde ve sonrasında karşılaştıkları sorunlara yer verilmiştir. Çalışma sonunda kadınların boşanma kararını alırken oldukça zorlandıkları ve bir çok kere düşünme ihtiyacı duydukları, boşanma kararını almayı zorlaştıran faktörlerin başında çocukların geleceği hakkında duyulan kaygının, çevredeki insanların vereceği tepkilerden çekinmenin ve kadınların ekonomik bir güvenceye sahip olmamalarının geldiği belirlenmiştir.Divorce is the termination of the marital relationship, by the married couple who cannot meet expectations of each other, through taking legal action. Women are disadvantaged relative to men during divorce and postdivorce processes. In this study, ten divorced women were interviewed by using in-depth interview technique about the factors that affect men the problems that they face during divorce and post-divorce processes. conclusion, the women are forced quite a while the divorce and they need to think a lot of times. The main factors that make it difficult to get the divorce decreases the concerns about the future of their children, the possible reactions of the people around and the loss of economic security