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  • 1
    Publication Date: 2014-11-11
    Description: Publication date: Available online 4 November 2014 Source: International Journal of Production Economics Author(s): Klaus Reinholdt Nyhuus Hansen , Martin Grunow Shorter product life cycles and the resulting increase in new product introductions boost the importance of product launch operations. In the pharmaceutical sector, product launch operations are of particular importance, as companies seek to reduce time-to-market to better exploit patent protection. Large volumes of product need to be ready to fill the downstream supply chain immediately at market launch. Building up the required inventory is, however, connected to several risks. In addition to the risk associated with the lack of demand information for a new product, there are several risks unique to the pharmaceutical sector. After approval by central authorities such as the FDA or EMA, a new drug still needs to receive market authorization, which is in most cases granted by some local authorities - in Europe, for example, by more than 30 national and regional bodies. The duration of these different market authorization processes as well as their outcomes (e.g. price and reimbursement levels, requirements of label or leaflet changes) are highly uncertain. We develop a two-stage stochastic model to support market launch preparation decisions. It trades off the costs of accepting these risks, for example by risk packaging before authorization, against the lost revenue caused by risk-averse operations. The model is applied to a case based on an empirical study. Our approach results in significant savings compared to current practices. We hereby provide an example of how quantitative methodology can provide valuable decision support for product launch operations, even when complex regulatory affairs need to be considered.
    Print ISSN: 0925-5273
    Electronic ISSN: 1873-7579
    Topics: Technology , Economics
    Published by Elsevier
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  • 2
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    Food and Agriculture Organisation of the United Nations (FAO)
    Publication Date: 2023-06-29
    Description: The contamination of the environment with whole plastics or pieces thereof (microand nanoplastics) is the subject of extensive discussion nowadays in academia and the media. In addition to environmental matrices, micro- and nanoplastics have been detected in fishery products and other important food commodities, with concerns over their impact on human health. Food consumption is considered one of most significant routes of human exposure to these small plastic particles. Such concerns may arise not only from the exposure to reactive monomers in the otherwise biologically inert polymer structure, but also from their associated contaminants. Many studies have reported neurotoxicity, oxidative stress and immunotoxicity among the main consequences of exposure to micro- and nanoplastics. This document outlines the existing literature on the occurrence of microplastics and their associated contaminants in foods. It estimates the dietary exposure of consumers to these materials, highlights some knowledge gaps with respect to their relevance to public health, and offers some recommendations for future work on microplastic particles to support food safety governance.
    Type: Report , NonPeerReviewed
    Format: text
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  • 3
    Publication Date: 2023-10-09
    Description: Sustainable development is the 21st Century's wicked problem. After 40 years into this agenda have reversed only few unsustainable trends we hear the call for a paradigm shift, transformation, radical change or system innovations in order to finally change course. But what does this actually mean? And how do we put it into practice? This book describes the path ahead. It combines system transformation research with political economy and change leadership insights when discussing the need for a great mindshift in how human wellbeing, economic prosperity and healthy ecosystems are understood if the Great Transformations ahead are to lead to more sustainability. It shows that history is made by purposefully acting humans and introduces transformative literacy as a key skill in leading the radical incremental change strategies that wicked problems require, illustrating their nature through mapping pioneering practices and their commonalities.
    Keywords: ddc:300
    Repository Name: Wuppertal Institut für Klima, Umwelt, Energie
    Language: English
    Type: book , doc-type:book
    Format: application/pdf
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