Drug Safety, Pharmacoepidemiology, and Regulatory Decision Making

1988 ◽  
Vol 22 (4) ◽  
pp. 336-344 ◽  
Author(s):  
Robert C. Nelson
Keyword(s):  
Risk Assessment ◽  
Decision Making ◽  
Conceptual Framework ◽  
Knowledge Base ◽  
Case Studies ◽  
Drug Safety ◽  
Research Question ◽  
Regulatory Decision ◽  
Risk Manager ◽  
Interpretive Framework

The safety or risk assessment of a pharmacotherapeutic agent begins early in its development and continues throughout its use cycle. The practice of pharmacoepidemiology is the art of using the sciences and the tools of science to generate information about pharmaceutical outcomes, including associated risks, in the postmarketing environment. A pharmacoepidemiologist must be capable of functioning with a matrix constructed of three components: a knowledge base, a conceptual framework, and an interpretive framework. From this perspective one can establish surveillance schemes, or understand a posed research question, select strategies, apply methodologies, and interpret the results of purposeful investigations. When conveyed to the risk manager, appropriately interpreted results of a properly conducted risk assessment can be used in regulatory decision making. Seven case studies are presented as examples of this approach.

Learner-Developed Case Studies on Ethics

2018 ◽  
pp. 131-163
Author(s):  
Lesley S. J. Farmer
Keyword(s):  
Higher Education ◽  
Decision Making ◽  
Knowledge Base ◽  
Case Studies ◽  
Ethical Behavior ◽  
Critical Analysis ◽  
Ethical Standards ◽  
Professional Lives ◽  
The Creation

This chapter explains how case studies can be used successfully in higher education to provide an authentic, interactive way to teach ethical behavior through critical analysis and decision making while addressing ethical standards and theories. The creation and choice of case studies is key for optimum learning, and can reflect both the instructor's and learners' knowledge base. The process for using this approach is explained, and examples are provided. As a result of such practice, learners support each other as they come to a deeper, co-constructed understanding of ethical behavior, and they make more links between coursework and professional lives. The instructor reviews the students' work to determine the degree of understanding and internalization of ethical concepts/applications, and to identify areas that need further instruction.

scholarly journals Bringing the boys back home: Campaign promises and US decision-making in Iraq and Vietnam

Politics ◽  
2020 ◽  
pp. 026339572093720
Author(s):  
Andrew Payne
Keyword(s):  
Decision Making ◽  
Conceptual Framework ◽  
Case Studies ◽  
Electoral Politics ◽  
Electoral Accountability ◽  
Powerful Factor ◽  
Important Constraint ◽  
Conflict Initiation ◽  
Push And Pull ◽  
Electoral Calendar

This article argues that electoral politics acts as an important constraint on presidential decision-making in war. Going beyond the existing literature’s focus on cases of conflict initiation, it outlines how electoral pressures push and pull presidents away from courses of action which may otherwise be deemed strategically optimal. Importantly, however, these electoral constraints will not just apply on the immediate eve of an election but will vary in strength across the electoral calendar. Together, this conceptual framework helps explain why presidential fulfilment of rhetorical pledges made on the previous campaign trail may be belated and often inconsistent. To probe the plausibility of these arguments, case studies of the closing stages of the wars in Vietnam and Iraq are outlined, drawing on archival and elite interview material. These episodes demonstrate that electoral accountability can be a powerful factor affecting wartime decision-making, but its effect is non-linear, and not easily observed through a narrow focus on particular timeframes.

scholarly journals The Style As a Factor of Office Building Concentration Locations in European Cities

2017 ◽  
Vol 24 (1) ◽  
pp. 5-20
Author(s):  
Anna Bocian
Keyword(s):  
Decision Making ◽  
Case Studies ◽  
Research Method ◽  
Research Question ◽  
Office Building ◽  
City Development ◽  
Master Plans ◽  
Urban Structures ◽  
European Cities ◽  
Development Plans

Abstract Where should office building concentrations be located in cities? What kind of factors has an influence on its locations? The aim of the research is to examine factors of office locations in cities. Selected office building concentrations in European cities were investigated as case studies. The research method was the spatial decision paradigm. The style, one of the main elements of the paradigm, was selected to answer the research question. The style was defined a composition of existing urban structures. Basic elements of urban composition in selected European cities were examined closely. Research results are conditions of office building concentration locations in European cities in term of urban composition. Such knowledge should be a base of decision-making processe during preparing master plans and city development plans.

The Extension of Molecular and Computational Information to Risk Assessment and Regulatory Decision Making*

2006 ◽  
pp. 151-180 ◽  
Author(s):  
James Bus ◽  
Richard Canady ◽  
Tracy Collier ◽  
J William Owens ◽  
Syril Pettit ◽  
...  
Keyword(s):  
Risk Assessment ◽  
Decision Making ◽  
Regulatory Decision

The use of risk assessment in regulatory decision making: Time for a review

1981 ◽  
Vol 1 (3) ◽  
pp. 264-276 ◽  
Author(s):  
John T. Barr ◽  
Donald H. Hughes ◽  
Robert C. Barnard
Keyword(s):  
Risk Assessment ◽  
Decision Making ◽  
Regulatory Decision

Initiating and Managing Risk Assessments within a Risk Analysis Framework: FDA/CFSAN'S Practical Approach

2004 ◽  
Vol 67 (9) ◽  
pp. 2058-2062 ◽  
Author(s):  
ROBERT L. BUCHANAN ◽  
SHERRI DENNIS ◽  
MARIANNE MILIOTIS
Keyword(s):  
Risk Assessment ◽  
Decision Making ◽  
Risk Management ◽  
Risk Analysis ◽  
Risk Assessments ◽  
Analysis Framework ◽  
Regulatory Decision ◽  
Managing Risk ◽  
Risk Managers ◽  
The U.S

Management of risk analysis involves the integration and coordination of activities associated with risk assessment, risk management, and risk communication. Risk analysis is used to guide regulatory decision making, including trade decisions at national and international levels. The U.S. Food and Drug Administration Center for Food Safety and Applied Nutrition (CFSAN) formed a working group to evaluate and improve the quality and consistency of major risk assessments conducted by the Center. Drawing on risk analysis experiences, CFSAN developed a practical framework for initiating and managing risk assessments, including addressing issues related to (i) commissioning a risk assessment, (ii) interactions between risk managers and risk assessors, and (iii) peer review.

Risk assessment and regulatory decision making

1981 ◽  
Vol 19 ◽  
pp. 549-560 ◽  
Author(s):  
I.C. Munro ◽  
D.R. Krewski
Keyword(s):  
Risk Assessment ◽  
Decision Making ◽  
Regulatory Decision
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