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Research and Education Needs for Complex Generics.

ABSTRACT: Complex generics are generic versions of drug products that generally have complex active ingredients, complex formulations, complex routes of delivery, complex dosage forms, are complex drug-device combination products, or have other characteristics that can make it complex to demonstrate bioequivalence or to develop as generics. These complex products (i.e. complex generics) are an important element of the United States (U.S.) Food and Drug Administration's (FDA's) Generic Drug User Fee Amendments (GDUFA) II Commitment Letter. The Center for Research on Complex Generics (CRCG) was formed by a grant from the FDA to address challenges associated with the development of complex generics. To understand these challenges, the CRCG conducted a "Survey of Scientific Challenges in the Development of Complex Generics". The three main areas of questioning were directed toward which (types of) complex products, which methods of analysis to support a demonstration of bioequivalence, and which educational topics the CRCG should prioritize. The survey was open to the public on a website maintained by the CRCG. Regarding complex products, the top three selections were complex injectables, formulations, and nanomaterials; drug-device combination products; and inhalation and nasal products. Regarding methods of analysis, the top three selections were locally-acting physiologically-based pharmacokinetic modeling; oral absorption models and bioequivalence; and data analytics and machine learning. Regarding educational topics, the top three selections were complex injectables, formulations, and nanomaterials; drug-device combination products; and data analytics, including quantitative methods and modeling & simulation. These survey results will help prioritize the CRCG's initial research and educational initiatives.

SUBMITTER: Stern S

PROVIDER: S-EPMC8732887 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundThe article presents the psychometric parameters and implementation of the adult education needs inventory (AENI) questionnaire, which is designed to measure the key competences of adult educators. It was constructed on the concept of key competences as proposed by the Council of the European Union. This model of competences is inscribed in the concept of lifelong learning and does not concentrate on the compensatory functions of the competences but merely promotes the insight of educators into their self-development. This article presents the construction process and psychometrical properties of AENI.Materials and methodsThe reliability of the test is confirmed by the inter-correlated results. The accuracy of the questionnaire was confirmed through principal component analysis (PCA). Apart from this, the accuracy of the theory was verified by a correlation between AENI and the Social Skills Profile (PROKOS), which measures the level of such social skills as assertiveness, cooperativeness, sociability, social resourcefulness, and social activeness. To check the accuracy of the theory, hypotheses were formulated which were related to both the correlated overall results (AENI and PROKOS) and the chosen scales.ResultsSix areas of need in development were distinguished: communication skills, multilingual and multicultural skills, digital skills, entrepreneurial skills, openness to science and culture, and social and civic skills. A low result on the scale indicates a need to develop a given skill because the respondent's skills are weak. Such information is vital for employers and educators who wish to diagnose the areas that need improvement. The measures of reliability and accuracy allow us to state that the questionnaire possesses acceptable psychometrical factors. This study contains propositions for further improvement of the questionnaire and a key to interpreting the research results.ConclusionAdult education needs inventory questionnaire is a reliable research tool that can be used to assess the competences of adult educators. Also, it can be considered a voice of discussion regarding the necessity of raising the quality of education and raising the awareness of the education needs of individual adult educators and organizations that benefit from their services.

Project description:One current challenge in the psychology of education is identifying the teaching strategies and learning contexts that best contribute to the learning of all students, especially those whose individual characteristics make their learning process more difficult, as is the case for students with special needs. One main theory in the psychology of education is the sociocultural approach to learning, which highlights the key role of interaction in children's learning. In the case of students with disabilities, this interactive understanding of learning is aligned with a social model of disability, which looks beyond individual students' limitations or potentialities and focuses on contextual aspects that can enhance their learning experience and results. In recent years, the interactive view of learning based on this theory has led to the development of educational actions, such as interactive groups and dialogic literary gatherings, that have improved the learning results of diverse children, including those with disabilities. The aim of this paper is to analyze the social impact achieved by a line of research that has explored the benefits of such successful educational actions for the education of students with special needs. National and European research projects based on the communicative methodology of research have been conducted. This methodology entails drawing on egalitarian dialogue with the end-users of research - including teachers, students with and without disabilities, students' relatives and other community members - to allow an intersubjective creation of knowledge that enables a deeper and more accurate understanding of the studied reality and its transformative potential. This line of research first allowed the identification of the benefits of interactive learning environments for students with disabilities educated in mainstream schools; later, it allowed the spreading of these actions to a greater number of mainstream schools; and more recently, it made it possible to transfer these actions to special schools and use these actions to create shared learning spaces between mainstream and special schools. The improvement of the educational opportunities for a greater number and greater diversity of students with special needs evidences the social impact of research based on key contributions of the psychology of education.

Project description:BACKGROUND:There is an increasing number of pediatric urgent care centers that are largely staffed by pediatric residency graduates. It is unclear if pediatric residency adequately prepares a physician to fully and successfully provide care in an urgent care setting. The goal of this study is to conduct an assessment of urgent care directors' perceptions of recent pediatric residency graduates' preparedness to successfully provide pediatric urgent care after graduation. METHODS:This is a 2018 cross-sectional survey of all pediatric emergency medicine division chiefs in the United States and all pediatric urgent care directors who are members of the Society for Pediatric Urgent Care. An electronic survey was distributed consisting of eight multiple choice questions regarding perceived preparedness and knowledge gaps of recent pediatric residency graduates for independent practice in urgent care. Descriptive statistics were used to analyze results and qualitative data were analyzed via an inductive thematic approach. RESULTS:Forty-two percent (65/154) of surveys were completed. No respondents believed that a recent pediatric residency graduate would be adequately prepared to independently practice in a pediatric urgent care and 81% of respondents recommended some additional training. Most respondents described this training as important (46%) or very important (35%). Most respondents recommended between 6 months and 1 year as the appropriate amount of time to achieve competency. CONCLUSIONS:Despite the growing number pediatric residency graduates staffing pediatric urgent care centers, the majority of surveyed pediatric emergency medicine division chiefs and pediatric urgent care directors do not think that pediatric residency adequately prepares graduates to successfully provide urgent care to pediatric patients. We recommend further exploration of gaps in knowledge of recent pediatric residency graduates as a next step towards developing systems for further training for pediatric residency graduates to gain competency in urgent care management.

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Research and Education Needs for Complex Generics.

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