scholarly journals Research and Education Needs for Complex Generics

2021 ◽  
Author(s):  
Sydney Stern ◽  
Jill Coghlan ◽  
Vishalakshi Krishnan ◽  
Sam G. Raney ◽  
Andrew Babiskin ◽  
...  
Keyword(s):  
Data Analytics ◽  
Quantitative Methods ◽  
Oral Absorption ◽  
The United States ◽  
Complex Products ◽  
Drug Products ◽  
Physiologically Based Pharmacokinetic ◽  
Methods Of Analysis ◽  
Survey Results ◽  
Research And Education

AbstractComplex 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.

scholarly journals Using Qualitative Approaches to Improve Quantitative Inferences in Environmental Psychology

2020 ◽  
Author(s):  
Neil Anthony Lewis ◽  
Mario Bravo ◽  
Sarah Naiman ◽  
Adam R Pearson ◽  
Rainer Romero-Canyas ◽  
...  
Keyword(s):  
Qualitative Research ◽  
Quantitative Methods ◽  
Environmental Psychology ◽  
The United States ◽  
Environmental Issue ◽  
Qualitative And Quantitative Methods ◽  
Qualitative Approaches ◽  
Survey Results ◽  
Current Article ◽  
Qualitative Component

This article describes the qualitative approach used to generate and interpret the quantitative study reported by Song and colleagues’ (2020) in their article, “What counts as an ‘environmental’ issue? Differences in environmental issue conceptualization across race, ethnicity, and socioeconomic status.” Song and colleagues (2020) describe the results of a survey documenting that, in the United States, White and high-SES respondents perceive environmental issues differently than their non-White and lower-SES counterparts, reflecting structural differences in environmental risks. While Song and colleagues (2020) discuss the survey results in detail, the discussion of the qualitative research that led to the creation of that survey was limited due to space constraints. The current article provides a more holistic account of the methods behind the Song and colleagues (2020) study by discussing the qualitative component of the research in detail. In addition to discussing how the qualitative research complements and critically informs the findings reported by Song et al., we also consider the broader implications and value of integrating qualitative and quantitative methods in environmental psychology.

The Three Rs in Research and Education: A Long Road Ahead in the United States

1996 ◽  
Vol 24 (2) ◽  
pp. 151-158 ◽  
Author(s):  
F. Barbara Orlans
Keyword(s):  
United States ◽  
Animal Experiments ◽  
The United States ◽  
Education Student ◽  
Funding Sources ◽  
Research And Education ◽  
The Right ◽  
Student Projects ◽  
Institutional Oversight ◽  
The Three Rs

Attitudes toward the Three Rs concept of refinement, reduction and replacement in the United States in research and education are widely divergent. Positive responses have come from several sources, notably from four centres established to disseminate information about alternatives. Funding sources to support work in the Three Rs have proliferated. The activities of institutional oversight committees have resulted in the nationwide implementation of important refinements. In the field of education, student projects involving pain or death for sentient animals have declined, and the right of students to object to participation in animal experiments on ethical grounds has been widely established. However, there is still a long way to go. Resistance to alternatives is deep-seated within several of the scientific disciplines most closely associated with animal research. The response of the National Institutes of Health to potentially important Congressional directives on the Three Rs has been unsatisfactory. The prestigious National Association of Biology Teachers, which at first endorsed the use of alternatives in education, later rescinded this policy, because of opposition to it. An impediment to progress is the extreme polarisation of viewpoints between the biomedical community and the animal protectionists.

Greener than Others? Exploring Generational Differences in Green Purchase Intent

2021 ◽  
pp. 147078532110341
Author(s):  
Chang-Dae Ham ◽  
Un Chae Chung ◽  
Woo Jin Kim ◽  
Seo Yoon Lee ◽  
Sang-Hwa Oh
Keyword(s):  
Generational Differences ◽  
Social Intelligence ◽  
The United States ◽  
Purchase Intentions ◽  
Generation Gap ◽  
Purchase Intent ◽  
Consumer Socialization ◽  
Survey Results ◽  
Nationally Representative ◽  
Practical Implications

This study explored the generation gap in American consumers’ green perceptions and purchase intentions across four generations (Gen Z, Y, X, and Baby Boomers) from the perspectives of consumer socialization and social intelligence. Analyzing a nationally representative sample of adults in the United States ( N = 19,450), the survey results revealed that the American consumer’s green norms and beliefs varied by generation. A series of multiple regression analyses showed that each generation had similar but idiosyncratic beliefs in purchasing products from green companies. Theoretical and practical implications are discussed.

The use of the United States FDA programs as a strategy to advance the development of drug products for neglected tropical diseases

2014 ◽  
Vol 40 (11) ◽  
pp. 1429-1434 ◽  
Author(s):  
Kristina Sachs-Barrable ◽  
Jocelyn Conway ◽  
Pavel Gershkovich ◽  
Fady Ibrahim ◽  
Kishor M. Wasan
Keyword(s):  
United States ◽  
Neglected Tropical Diseases ◽  
The United States ◽  
Tropical Diseases ◽  
Drug Products

Health Care Cost Containment in Large American Cities

1989 ◽  
Vol 18 (1) ◽  
pp. 87-100 ◽  
Author(s):  
Perry Moore
Keyword(s):  
Health Care ◽  
Cost Containment ◽  
Local Governments ◽  
Health Care Cost ◽  
The United States ◽  
Public Agencies ◽  
The Public ◽  
Survey Results ◽  
The Cost ◽  
American Cities

This research provides information about the health care cost containment efforts of local governments and agencies across the United States, particularly in large American cities. Survey results indicate that while the public sector lags behind the private sector, public agencies are beginning to match the cost containment efforts of private employers. While initiation of these efforts represents considerable recent progress, their tangible benefits are not yet apparent.

Identifying New Directions for African Studies: Methodology Report and Survey Results

2002 ◽  
Vol 30 (2) ◽  
pp. 76-88
Author(s):  
Larry W. Bowman ◽  
Diana T. Cohen
Keyword(s):  
United States ◽  
Graduate Students ◽  
The United States ◽  
African Studies ◽  
The Internet ◽  
Coverage Error ◽  
New Directions ◽  
Survey Results

The sample frame was constructed over several months through the combined efforts of three graduate students and Prof. Larry W. Bowman. Using the Internet whenever possible, and backed by the assistance of colleagues from many institutions, we constructed a sample frame of 1,793 U.S.-based Africanists. Our sample frame includes 46 percent more Africanists than the 1,229 individual U.S. members of the African Studies Association (ASA) in 2001 (1,112 individual members and 117 lifetime members). In all cases we allowed institutions to self-define who they considered their African studies faculty to be. By assembling this broad sample frame of African studies faculty, we probe more deeply into the national world of African studies than can be done even through a membership survey of our largest and most established national African studies organization. The sample frame for this study approximates a full enumeration of the Africanist population in the United States. Therefore, data collected from samples drawn from this frame can with some confidence be generalized to all Africanists in the United States, with minimal coverage error.

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