Food and Drug Administration (FDA's) Risk based approach guidance document helps clinical investigation sponsors to develop monitoring plans and strategies that are risk-based for medical products’ investigational studies, including biological and human drug products and medical devices. This guidance’s overarching goal is to promote protection of the human subject and clinical trial data quality through focusing the sponsor oversight on the most essential matters of reporting and study conduct . On the other hand, European Medicines Agency’s (EMA's) reflection paper on risk based approach to quality management is a document that helps clinical investigation sponsors to design, conduct, perform, ...
Validation Article Reviews Samples For Students
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In their coauthored article, Kim Tallbear and Deborah A. Bolnick write about a relatively new practice of determining ancestry by employing DNA tests. As of 2004, there are at least fourteen companies that provide Native American DNA tests, reflecting the growing trend of people using this method in order to validate their ancestry (Bolnick, Tallbear). In their article, the two scientists discuss several negative implications of these tests as well as their harmful effects on Native American tribes.
The one prevailing motivation for taking these tests seems to be their supposed power to validate people’s ethnic identity and ...
The Quality by Design (QbD) does well in defining the good practices that need to be adhered to in the development of pharmaceutical products. The Quality by Design (QbD) is displayed as a very systematic approach to the development of drugs. It emphasizes on process control and understanding of the processes that define how a product is developed. It is evident that Quality by Design is based on strong scientific ground and a quality manner of managing risks.
The Q8 (R2) demonstrates by example when it defines the QbD approach. The first step in the QbD approach is determining ...
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Sathyanarayanan Rajendran, and John A. Gambatese (2009) in their research on the “Development and Initial Validation of Sustainable construction Safety and Health Rating System,” seek to validate the sustainable construction safety and health (SCSH) rating system. The main focus of the authors was to establish a rating system on the degree of implementation of safety and health elements in construction. The main target audiences are the health professional from various sectors of the construction industry, the contractor, and construction regulation agencies. The authors used the Delphi research methodology to develop the SCSH. A Delphi survey was used in the research ...
Critical Review: “Like” and “Check-in”: How Hotels Utilize Facebook as an Effective Marketing Tool
Critical Review: “Like” and “Check-in”: How Hotels Utilize Facebook as an Effective Marketing Tool
1 Introduction
This paper is a critique of the research traditions utilized in the ‘”Like” and “Check”: How hotels utilize Facebook as an effective marketing tool’, written by Kelly V Phelan, Hsiang-Ting Chen, and Matthew Haney, and published in the Journal of Hospitality and Tourism Technology, Volume 4, Issue 2, 2013. The critique will explore the philosophical background of the article and the logical approach followed by the authors in the process of conducting the research. It will also evaluate the research ...
Research Methods in Human Development:
“Child Care and the Development of Behavior Problems among Economically Disadvantaged Children in Middle Childhood”
Child Care and the Development of Behavior Problems among Economically Disadvantaged Children in Middle Childhood: A Review
The peer-reviewed article is the work of Votruba-Drzal et al. (2010). The focus of the study is to determine whether the level of childcare quality is interrelated to the development of behavioral problems among economically disadvantaged children in middle childhood (Votruba-Drzal et al., 2010). According to the thesis statement in the article, when a child transitions into formal schooling, indications of lower behavioral problem and better ...
