Phases Of Development Process Research Articles

Process Validation in Pharmaceutical Product Development: An Overview

As per GMP process validation is very important and required part in product development. Process Validation is required for ensuring and providing the documentary evidence and also required for giving the Surety that process by which the formulation is prepared is capable of consistently producing the product of required quality and purity.
 A validated manufacturing process is one which has been proved to do what it purports on is represented to do. The proof of validation is obtained through the collection and evaluation of data, preferably, beginning from the process development phase and Continuing through the production phase. Validation necessarily includes process qualification (the qualification of materials, equipment Systems, buildings, personnel), but it also includes the control on the entire process for repeated batches or runs. This article gives a general introduction and overview about process validation in pharmaceutical manufacturing process and its importance.
 Keywords: GMP, Validation, validation manufacturing process.

Spiritual Growth and Social Entrepreneurship: Understanding the integration of spirituality and social entrepreneurial process

The business world today is moving from capitalism to social entrepreneurship. Social entrepreneurs view a social mission as an explicit and central one than following the path of individual wealth creation. Seizing opportunities and utilizing resources are the key factors that influencing entrepreneurial process. Entrepreneur’s belief system is shaped or process of interpretation that makes entrepreneurs pursue solutions to social problems. Transcends from wealth creators to social warriors may be explained by focusing on their spiritual orientation (Ganzin, Islam, & Suddaby, 2020). The objective of the study is to explore the connection of spirituality development to social entrepreneurial process of social entrepreneurs. The paper offers a new theoretical conceptualization in relation to understanding how spiritual growth influences social entrepreneurs. Thus, the paper tries to build up the relationship between spiritual growth and social entrepreneurial process. As such, our paper strengthen the existing social entrepreneurship theory by introducing the spirituality dimension to the cognitive process and highlights the trigger points related to social entrepreneurial behavior that transcendence individual wealth creation. Furthermore, the linkage between the attributes of social entrepreneurial process and spiritual development phases is an eye opening to both spiritual and entrepreneurial studies.
 Keywords: Social entrepreneurship, Spiritual growth, Entrepreneurial process

New failure rate model for iterative software development life cycle process

Software reliability models are one of the most generally used mathematical tool for estimation of reliability, failure rate and number of remaining faults in the software. Existing software reliability models are designed to follow waterfall software development life cycle process. These existing models do not take advantage of iterative software development process. In this paper, a new failure rate model centered on iterative software development life cycle process has been developed. It aims to integrate a new modulation factor for incorporating varying needs in each phase of iterative software development process. It comprises imperfect debugging with the possibility of fault introduction and removal of multiple faults in an interval as iterative development of the software proceeds. The proposed model has been validated on twelve iterations of Eclipse software failure dataset and nine iterations of Java Development toolkit (JDT) software failure dataset. Parameter estimation for the proposed model has been done by hybrid particle swarm optimization and gravitational search algorithm. Experimental results in-terms of goodness-of-fit shows that proposed model has outperformed Jelinski Moranda, Shick Wolverton, Goel Okummotto Imperfect debugging, GS Mahapatra, Modified Shick Wolverton in 83.33% of iterations for eclipse dataset and 77.77% of iterations for JDT dataset.

Challenges in transfer of gas-liquid reactions from batch to continuous operation: dimensional analysis and simulations for aerobic oxidation

The transfer of gas-liquid reactions from conventional batch processes into continuous operation using milli and micro reactors is claimed as an important step towards process intensification. Importantly, this transfer step should be realized in an early phase of process development, already, in order to minimize research efforts towards the undesired operation strategy. The main challenge of this approach, therefore, arises from lack of knowledge in the early stage of process development and the resulting system with high degrees of freedom. This contribution presents an approach to tackle this challenge by means of mathematical modelling and simulation for the aerobic oxidation of 9,10-dihydroanthracene (DHA) catalyzed by polyoxometalates (POMs) being used as example for gas-liquid reactions. The reaction was chosen as it provides sufficient complexity, since it consists of three consecutive oxidation steps of DHA and a parallel catalytic redox-cycle according to a Mars-van-Krevelen mechanism. It also provides the challenge of unknown reaction kinetics, which have been estimated in this contribution. The dimensionless balance equations for reactor modeling are derived and parametrized based on early stage experimental results obtained in batch operation mode. The discrimination between batch and continuous operation was performed by means of characteristic dimensionless numbers using the identical mathematical model for comparability reasons. The model was used to perform sensitivity studies with emphasis on the interplay between mass transfer characteristics and reaction kinetics for both the batch and continuous operation mode. The simulation results show that the performance of both operation modes mainly depend on the oxidation state of the POM catalyst, which is caused by the differences in oxygen availability. Therefore, results obtained in batch operation mode are prone to be masked by mass transfer issues, which affects catalyst and reactor development at the same time and may thus cause maldevelopments. With respect to process development it can thus be concluded that the transfer from batch to continuous operation together with mathematical modeling is important in an early phase, already, in order to detect limitations misleading the development. Finally, even simple models with roughly estimated parameters from preliminary experiments are shown to be sufficient in the early phase and can systematically be improved, in the subsequent phases.Graphical abstract

User-Centered Development of a Mobile App for Biopsychosocial Pain Assessment in Adults: Usability, Reliability, and Validity Study

BackgroundPain-related mobile apps targeting pain assessment commonly limit pain assessment to pain behaviors and physiological aspects. However, current guidelines state that pain assessment should follow the biopsychosocial model, clearly addressing biological, psychological, and social aspects of the pain experience. Existing reviews also highlight that pain specialists and end users are not commonly involved in the development process of mobile apps for pain assessment, negatively affecting the quality of the available apps.ObjectiveThis study aimed to develop a mobile app for pain assessment (AvaliaDor) and assess its usability, validity, reliability, and measurement error in a sample of real patients with chronic pain recruited from a physiotherapy clinic.MethodsThis study was divided into 2 phases: phase 1—development of the AvaliaDor app; and phase 2—assessment of the apps’ usability, reliability, measurement error, and validity. AvaliaDor was developed (phase 1) based on the literature and the recommendations of physiotherapists and patients with pain in cycles of evaluation, inclusion of recommendations, and reevaluation until no further changes were required. The final version of the app was then tested in patients with musculoskeletal pain attending a private physiotherapy practice (phase 2) who were asked to use the app twice on 2 consecutive days for reliability purposes. In addition, participants had to complete a set of paper-based scales (Brief Pain Inventory, painDETECT, Pain Catastrophizing Scale, and Tampa Scale for Kinesiophobia), which were used to assess the validity (criterion validity and hypothesis testing) of the app, and the Post-Study System Usability Questionnaire was used to assess its usability.ResultsThe development process (phase 1) included 5 physiotherapists external to the research team and 5 patients with musculoskeletal pain, and it resulted in the creation of an app named AvaliaDor, which includes an assessment of pain intensity, location, and phenotype; associated disability; and the issues of pain catastrophizing and fear of movement. A total of 52 patients with pain (mean age 50.12 years, SD 11.71 years; 39 females) participated in phase 2 and used the app twice. The Pearson correlation coefficient between the scores on the paper-based scales and the app ranged between 0.81 and 0.93 for criterion validity and between 0.41 and 0.59 for hypothesis testing. Test-retest reliability was moderate to good (intraclass correlation coefficient between 0.67 and 0.90) and the score for usability was 1.16 (SD 0.27), indicating good usability.ConclusionsA mobile app named AvaliaDor was developed to assess the intensity, location, and phenotype of pain; associated disability; and the issues of pain catastrophizing and fear of movement in a user-centered design process. The app was shown to be usable, valid, and reliable for assessing pain from a biopsychosocial perspective in a heterogeneous group of patients with pain. Future work can explore the long-term use of AvaliaDor in clinical contexts and its advantages for the assessment and management of patients with pain.

The Researchers' Perspective: For and By the Community

In this study, we describe the innovative and rigorous phased process used to compose the American Association of School Librarians (AASL) National School Library Standards (AASL, 2018). We begin by recounting previous standards iterations and compared their development processes to the most recent process used during the development of the AASL Standards. After we detail the development timeline and process phases, we conclude with implications for best practices in standards development for school librarians, professional leaders, and practitioners.

Towards a sustainable conceptual design of mechatronic systems application to a regenerative braking system

Mechatronic systems use the synergies from the interaction of electronics, mechanics and information technology. They include a wide range of interconnected components using application specific software, which makes their design a multi domain exercise. In contrast to the fact that the improvement of the functionality of the mechatronic system has been the main objective of the design in the past, nowadays a special focus on the environmental aspects is needed in order to create sustainable products. As a matter of fact, a sustainable design methodology for mechatronic systems is needed. In this paper, we propose a sustainable conceptual design methodology for mechatronic systems on the example of a regenerative braking system. Thus, we outline the proposed methodology going from the specifications to defining a set of candidate solutions satisfying requirements including environmental ones by using a new tool which we nominate Design Environmental Matrix. The proposed methodology allows us to considerate environmental aspects in the earlier phase of mechatronics system development process.

Urban rent at risk: the point of viewof private investors [Rendita urbanaa rischio: la prospettiva degli investitori privati

Urban transformation and regeneration interventions are complex processes in which a multitude of actors act in order to generate an overall value higher than the investment and proportional to the risks, related to each phase of real estate development process. The trade-off between risk and return is one of the essential element in investment decisions, even more in the context of urban transformations projects characterized by long-term time horizons, hence the difficulty for investors to predict the future. In this context, the paper proposes a reflection on the relationship between return and risk in urban transformation and regeneration interventions, focusing on the private investor’s perspective. A first questionnaire was proposed to a selected panel of experts, as pre-test, in order to highlight how the different actors involved in development processes perceive risk and how their adversity varies due to their role and the development phase. The first results of the pre-test phase have pointed out interesting aspects that deserve an in depth investigation through a survey extended to a larger sample, such as the importance of the involvement of private operators and the use of multidimensional and multi-stakeholder models to support risk management.

Development of a parametric packaging and sizing tool for autonomous electric bus system

The demand for autonomous electric public transport is increasing globally. New vehicle models and variants are increasing the development complexity and hence the overall development time. Therefore, there is a requirement for a vehicle-packaging tool that can translate user inputs into an optimised vehicle package and can be visualised instantly. The aim of this paper is to develop a parametric tool for designing different concepts for electric autonomous buses. The scope of application is intended in the early phase of the vehicle development process to enable a fast and efficient creation of a flexible bus concept. Through a graphical user interface (GUI), the user is able to size and select all the required components for the autonomous vehicle concepts. The vehicle specification is initiated by selection of one of the three classes of vehicle, the desired number of passengers and then the bus interior’s seat arrangement design. An appropriate powertrain and chassis will then automatically be configured in the next steps. The HVAC simulation allows for the design of different components of the refrigeration circuit to ensure proper cabin temperature. For evaluating the concept, the energy consumption is analysed through simulations, and an estimated initial cost of vehicle concepts and individual systems completes the concept. A spider chart summarises all characteristics and offers an overview of the vehicle concept, providing the possibility to compare with other concepts simultaneously. The tool can create 9600 different bus concepts and provides interfaces for expansion.

DESAFIOS E ENCAMINHAMENTOS RELACIONADOS AO ENFRENTAMENTO DOS/AS PROFESSORES/AS A UM CURRÍCULO INOVADOR – O CURSO MÉDICO DE UMA UNIVERSIDADE PÚBLICA

Investigar a dinâmica do processo de mudança curricular de um Curso de Medicina na perspectiva dos docentes. Trata-se de um estudo de caso, com entrevistas individuais e foco na análise dos incidentes críticos e nos repertórios linguísticos sobre o processo de mudança curricular. A análise destaca a importância da participação docente no cotidiano da sala de aula e em todas as fases do processo de elaboração, revisão e inovação curricular e da utilização das abordagens de Educação Permanente, Planejamento participativo, Formação e participação docente, das Redes formais e informais de relações; do desenvolvimento de Equipe e da gestão dos conflitos

Mechanisms of Origin and Classification of Out-of-Plane Fiber Waviness in Composite Materials—A Review

Out-of-plane fiber waviness, also referred to as wrinkling, is considered one of the most significant effects that occur in composite materials. It significantly affects mechanical properties, such as stiffness, strength and fatigue and; therefore, dramatically reduces the load-carrying capacity of the material. Fiber waviness is inherent to various manufacturing processes of fiber-reinforced composite parts. They cannot be completely avoided and thus have to be tolerated and considered as an integral part of the structure. Because of this influenceable but in many cases unavoidable nature of fiber waviness, it might be more appropriate to consider fiber waviness as effects or features rather than defects. Hence, it is important to understand the impact of different process parameters on the formation of fiber waviness in order to reduce or, in the best case, completely avoid them as early as possible in the product and process development phases. Mostly depending on the chosen geometry of the part and the specific manufacturing process used, different types of fiber waviness result. In this study, various types of waviness are investigated and a classification scheme is developed for categorization purposes. Numerous mechanisms of wrinkling were analyzed, leading to several recommendations to prevent wrinkle formation, not only during composite processing, but also at an earlier design stage, where generally several influence factors are defined.

FORM INCEPTION TO EXECUTION: DEVELOPMENT OF ADOLESCENT IDEAS INTO CREATIVE SUCCESSFUL ENDEAVORS

The creative sense of new ideas is often not realized due to a dearth of thoughtful consideration of how to brand these ideas meaningful after their inception. What happens between idea generation and implementation—during what we call the idea development phase—has often been overlooked. To support idea creators in successfully materializing their “adolescent” ideas, we suggest a theory about diverse activities that idea creators can utilize to specify, further progress, or improve an idea in the phase of idea development process. Inspired by adolescence development learning, our model reveals the different physiological, psychological, and emotional developments that help to take ideas forward after they have been generated. The study contributes to the literature on creativity and innovation by more closely considering what happens to ideas in their development phase and by revealing how ideas can be improved so that the realistic and best one is selected for execution.

Merck KGaA helps scale COVID-19 vaccine

The University of Oxford’s Jenner Institute and Merck KGaA have developed a manufacturing process for the institute’s COVID-19 vaccine candidate, ChAdOx1 nCoV-19. Using technology developed by Merck, the partners have reduced the process development phase from 12 months to 2. A trial of the vaccine, which is based on an adenovirus vaccine vector and the SARS-Cov-2 spike protein, will start soon and the vaccine could be ready to roll out by the fall, Jenner says.

Impacting the B2B-Business Development Process: Social Media Usage within a Global Software Environment

The thesis aims to explore and explain how Social Media impacts the B2B-Business Development process in a global software environment. Mixed-methods uncover the leading media platforms applied in the Business Development process cycle. The thesis produced a model, illustrating two dimensions of Social Media Business Usage, four critical Business Development process phases, and their impact on Performance mediated by Social Capital. To extend generalizability, future research may focus on testing the model for New Business Development exclusively. Significant contributions are classifying relevant Social Media platforms, distilling the process phases with the greatest impact on performance. The creation of new indices advances the performance discussion, and the typology of Business Developers capitalises on optimising the process sequence.

Optimization of Interval Type-2 Fuzzy Logic System for Software Reliability Prediction

Since real world application is fraught with high amount of uncertainty, such as applicable to software reliability, there should be a method of handling the uncertainty. This paper presents a model to properly handle uncertainty in software data for effective prediction of the reliability of software at the early phase of software development process. In this paper we employed a Takagi-Sugeno-Kang (TSK)-based interval type 2 fuzzy logic systems with artificial neural network learning for the prediction of software reliability. The degree of membership grades of the interval type 2 fuzzy sets (IT2FSs) are obtained using interval type Gaussian membership function with fixed mean and uncertain standard deviation. The parameters of the IT2FLS membership functions are optimized using gradient descent (GD) back-propagation algorithm. As inputs to the system, reliability relevant software requirement metrics and the software size metrics are used. The proposed new approach makes use of qualitative data of requirement metrics of twenty three real software projects to examine its predictive ability. The performance of the model is evaluated using five performance metrics and found to provide better results when compared with existing approaches.

Dynamic Mergers Effects on R&D Investments and Drug Development Across Research Phases in the Pharmaceutical Industry

Pharmaceutical firms spend increasing amounts in mergers and acquisitions (M&As), which raises the question of whether sufficient investment is left after mergers to further develop firms’ internal drug development capability. We evaluate the effects of M&As on firms’ post-merger R&D investments and drug development capabilities across drug development phases. This study builds on a novel database that enables us to evaluate the post-merger effect at the research project level and across development phases. A further novel feature of the study is allowing measurement errors to enter firms’ R&D investments. Our study adopts a structural equation modeling approach, which is appropriate for evaluating a system of equations through which we examine the direct and indirect merger effects on R&D capabilities across development phases. We find that M&As have a strong effect on firms’ drug development at the late development phases through economies of scope. At the early development phases, M&As serve to replenish firms’ drug pipelines. The study shows that M&As have a direct and negative effect on firms’ R&D investments. However, the overall effect on R&D investments accounting for enhanced post-merger R&D capabilities and product approvals turns out to be positive. M&As can be an effective instrument for firms to acquire drug development knowledge and technology in late stages of the development process (Phases 3 clinical testing and regulatory filing). Our study provide empirical evidence that investments in M&As in late stage of drug development help firms’ growth and increase firms revenue.

Towards Evaluation the Cornerstone of Smart City Development: Case Study in Dalat City, Vietnam

Over the past decade, the process of urbanization in Vietnam has taken place rapidly, leading to strong social disturbances and causing cities to face many problems. All these challenges have put pressure on urban planning and governance to make adjustments to allow cities to become livable. Moreover, the quality of urbanization is reflected not only in growth but also in harmonious development in all aspects. The urban development process must accordingly be handled by more smart solutions. Smart city development is becoming a trend not only in urban areas all over the world but also in Vietnam. The paper aims to assess the initial phases of the smart city development process in Dalat City. It first evaluated a four-dimensional smart city’s strategic elements of city vision and transformation known as Strengths-Weaknesses-Opportunities-Threats. Then, based on these analytical characteristics, an adaptive model for development is suggested. This paper extends the previous research on smart cities and draws attention to further study on smart city development in Vietnam.

Optimizing requirement analysis by the use of meta-heuristic in search based software engineering

<p>Requirements analysis is the first phase of software development process and it is one of the main concerns of software engineers. The selection of requirements is a complex problem caused by the heterogeneity of the users and their varied interests and demands. In this paper, it is justified that their is a strong need of optimization in requirement analysis. The paper argues that requirement selection can be viewed as an application area of Search-Based Software Engineering(SBSE). The aim is to justify the claim that requirement engineering can be re-formulated as search problem to which meta-heuristic technique can be applied.</p>

Compliance of Public Elementary Schools with the Enhanced School Improvement Plan

This descriptive-comparative research was conducted to determine the compliance level of public elementary schools in Bacolod City Division with the Enhanced School Improvement Plan (E-SIP) as assessed by internal and external assessors when taken as a whole and when compared according to school demographics in the major phases of E-SIP development and implementation process. Likewise, it detailed the challenges and actions undertaken in the E-SIP compliance. Using the standardized SIP quality assessment tool, the results revealed a ‘satisfactory’ level of E-SIP compliance as a whole while ‘highly satisfactory’ levels in plan and act phases. It further showed significant differences in preparatory, assess and act phases for both school performance and designation of assessors. The results of the assessment were attributed to varying interpretation of some criteria and the absence of mode of verification in the E-SIP compliance. Hence, a policy recommendation was designed to attain successful E-SIP compliance of public elementary schools.

The Cost of Learning from Failures and Mistakes in Product Design: Reviewing the Literature

AbstractIn the design phase of product development (PD) process, most new products face significant uncertainties and risks. Uncertainty is typically associated with a lack of information, while learning is a process that acquires information. Therefore, learning fast and at low cost decreases the uncertainty and increases the efficiency of the product design phase. This paper investigates the concept of the cost of learning in PD's design phase. Reviewing the literature, we conceptualize the cost of learning and review the learning methods considering three aspects in the design phase of the PD process: (1) costs associated with learning from mistakes and failures, (2) learning methods and (3) categories of learners. This paper thus provides the conceptual foundations for future work to increase the efficiency of the PD process by reducing the cost of learning from mistakes and failures.